Merz North America Inc

FDA Filings

This page includes the latest FDA filings for Merz North America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Merz North America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ANTEIS SA

FDA Registration(s)

• Registration Number: 2135225
• FEI Number: 3003407669
• Name: Merz North America, Inc.
• Owner & Operator: Merz North America, Inc.
• Contact Address: 6501 Six Forks Road ; Raleigh NC 27615 US
• Official Correspondent:
  • Devon Allen
  • x-919-9857891-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4133 Courtney St., Suite 10 ; FRANKSVILLE, WI 53126 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

• Registration Number: 3013840437
• FEI Number: 3013840437
• Name: Merz North America, Inc.
• Owner & Operator: Merz North America, Inc.
• Contact Address: 6501 Six Forks Road ; Raleigh NC 27615 US
• Official Correspondent:
  • Devon Allen
  • x-919-9857891-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 13900 W. Grandview Parkway ; Sturtevant, WI 53177 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
Journee Firm Riche Broad Spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2023-10-25
Journee Firm Broad Spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2023-10-25
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2023-09-20
GUDID M2138700M05 MERZ NORTH AMERICA, INC.	Belotero Balance	2023-09-15
Journee Firm Broad Spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2023-07-11
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 Merz North America, Inc	Otc Medication	2023-07-11
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2023-06-29
Journee Firm Riche Broad Spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2023-03-15
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 Merz North America, Inc.	Otc Medication	2023-01-26
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2022-10-01
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2022-09-13
NDC 46783-100 Merz North America, Inc.	Journee Firm Broad Spectrum Sunscreen SPF 30	2022-05-01
Journee Firm Broad Spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2022-05-01
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 Merz North America, Inc	Otc Medication	2022-04-12
PMA P050052S134 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline	2022-02-02
PMA P050037S113 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2022-02-02
GUDID 08714729804796 MERZ NORTH AMERICA, INC.	Coaptite M0068903000	2022-01-19
Asclera Merz North America, Inc, Chemische Fabrik Kreussler & Co. GmbH	Prescription Medication	2021-11-04
PMA P050052S132 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine Implant	2021-10-21
PMA P050037S112 MERZ NORTH AMERICA, INC	RADIESSE Implant	2021-10-21
PMA P090016S046 MERZ NORTH AMERICA, INC	Belotero Balance + Lidocaine	2021-10-13
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2021-08-26
PMA P050052S131 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine Dermal Filler	2021-06-25
PMA P050052S130 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant and Radiesse Hands	2021-06-08
PMA P050037S111 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2021-06-08
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2021-04-28
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2020-12-22
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 Merz North America, Inc.	Otc Medication	2020-11-17
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 Merz North America, Inc	Otc Medication	2020-11-17
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2020-11-14
Prismplus Broad-Spectrum Sunscreen SPF 43 Merz North America, Inc	Otc Medication	2020-11-14
Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2020-11-14
PMA P090016S043 MERZ NORTH AMERICA, INC	Belotero Balance	2020-10-29
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2020-10-29
PMA P050052S127 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler	2020-10-23
PMA P050037S109 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-10-23
PMA P040047S063 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2020-10-23
PMA P050052S125 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler	2020-10-15
PMA P050037S107 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-10-15
PMA P040047S061 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2020-10-15
PMA P050052S126 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler	2020-10-14
PMA P050037S108 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-10-14
PMA P040047S062 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2020-10-14
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2020-09-03
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2020-08-04
PMA P050052S124 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler	2020-07-30
PMA P050037S106 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-07-30
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 Merz North America, Inc.	Otc Medication	2020-07-29
Prismplus Broad-Spectrum Sunscreen SPF 43 Merz North America, Inc	Otc Medication	2020-07-29
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 Merz North America, Inc	Otc Medication	2020-07-29
Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2020-07-29
PMA P050052S122 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler	2020-05-18
PMA P050037S104 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-05-18
PMA P040047S058 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2020-05-18
PMA P050052S121 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant, RADIESSE Hands AND Radiesse (+) Lidocaine Demral Filler	2020-04-15
PMA P050037S103 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2020-04-15
PMA P040047S057 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2020-04-15
PMA P050052S119 MERZ NORTH AMERICA, INC	Radiesse(+) Lidocaine	2020-03-17
PMA P090016S038 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler	2020-02-07
PMA P090016S035 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2020-02-06
PMA P090016S036 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler	2020-02-04
PMA P050052S118 MERZ NORTH AMERICA, INC	Radiesse Injecable Implant, Radiesse (+) Lidocaine Dermal Filler	2019-12-26
PMA P050037S101 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-12-26
PMA P050052S115 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler	2019-11-06
PMA P050037S098 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-11-06
PMA P040047S055 MERZ NORTH AMERICA, INC	Coaptite lnjectable lmplant	2019-11-06
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2019-11-06
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2019-10-31
GEA Merz North America, Inc.	CSH Cannula; STERiGLIDE	2019-10-24
PMN K180623 | OHV Merz North America, Inc.	Ulthera System	2019-10-23
PMN K180623 | IYO Merz North America, Inc.	Ulthera System	2019-10-23
Asclera Merz North America, Inc, Chemische Fabrik Kreussler & Co. GmbH	Prescription Medication	2019-09-12
PMA P090016S028 MERZ NORTH AMERICA, INC	Belotero Balance (+) Lidocaine	2019-08-29
PMA P090016S033 MERZ NORTH AMERICA, INC	Belotero Balance	2019-07-31
PMA P040047S052 MERZ NORTH AMERICA, INC	Coaptite	2019-06-26
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 Merz North America, Inc	Otc Medication	2019-06-25
Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2019-06-22
Prismplus Broad-Spectrum Sunscreen SPF 43 Merz North America, Inc	Otc Medication	2019-06-22
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 Merz North America, Inc.	Otc Medication	2019-06-20
PMA P090016S032 MERZ NORTH AMERICA, INC	Belotero Balance	2019-06-18
PMA P050052S114 MERZ NORTH AMERICA, INC	Radiesse Injectable Implany and Radiesse (+) Lidocaine Dermal Filler	2019-06-07
PMA P050052S113 MERZ NORTH AMERICA, INC	Radiesse (+) Lidocaine Dermal Filler	2019-06-07
PMA P050037S097 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-06-07
PMA P050037S096 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-06-07
PMA P040047S054 MERZ NORTH AMERICA, INC	Coaptite Injectable Implant	2019-06-07
PMA P040047S053 MERZ NORTH AMERICA, INC	Coaptite Injectable Implant	2019-06-07
PMA P050052S112 MERZ NORTH AMERICA, INC	Radiesse (+) Lidocaine Dermal Filler (1.5cc and 0.8cc)	2019-06-06
PMA P050037S095 MERZ NORTH AMERICA, INC	Radiesse 1.5cc and 0.8cc	2019-06-06
PMA P050052S111 MERZ NORTH AMERICA, INC	Radiessse Hands, and Radiesse (+) Lidocaine Dermal Filler	2019-05-17
PMA P050037S094 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-05-17
Xeomin Merz North America, Inc., Merz Pharma GmbH & Co. KGaA	Prescription Medication	2019-05-17
PMA P050052S110 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2019-05-03
PMA P090016S031 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2018-10-23
PMA P050052S105 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine 0.8cc and 1.5cc	2018-08-12
PMA P050037S089 MERZ NORTH AMERICA, INC	RADIESSE 0.8cc and 1.5cc	2018-08-12
PMA P090016S030 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2018-07-25
PMA P050052S109 MERZ NORTH AMERICA, INC	Radiesse (+)	2018-07-06
PMA P050052S106 MERZ NORTH AMERICA, INC	Radiesse (+) Lidocaine Dermal Filter	2018-07-06
PMA P050037S093 MERZ NORTH AMERICA, INC	Radiesse	2018-07-06
PMA P050037S090 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2018-07-06
PMA P050052S108 MERZ NORTH AMERICA, INC	Radiesse Hands, Radiesse (+) Lidocaine Dermal Filler	2018-07-05
PMA P050037S092 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2018-07-05
NDC 46783-223 Merz North America, Inc	Prismplus Broad-Spectrum Sunscreen SPF 43	2018-06-01
NDC 46783-222 Merz North America, Inc	Reactive Plus Anti-Oxidant Serum Plus Broad-spectrum SPF 45	2018-06-01
PMA P040047S051 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2018-05-15
Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30 Merz North America, Inc.	Otc Medication	2018-05-03
PMA P050052S104 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine Dermal Filler 1.5CC	2018-04-24
PMA P050037S088 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant 1.5CC	2018-04-24
PMA P090016S027 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2018-04-03
PMA P090016S026 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2018-04-02
GUDID 00186295000366 MERZ NORTH AMERICA, INC.	DeScribe Transparent PFD Patch	2018-03-29
GUDID 00186295000359 MERZ NORTH AMERICA, INC.	DeScribe Transparent PFD Patch	2018-03-29
GUDID 00186295000342 MERZ NORTH AMERICA, INC.	DeScribe Transparent PFD Patch	2018-03-29
PMA P090016S025 MERZ NORTH AMERICA, INC	Belotero Balance Dermal Filler	2018-03-28
PMA P050052S098 MERZ NORTH AMERICA, INC	Radiesse Hands, Radiesse (+) Lidocaine	2018-03-28
PMA P050037S082 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2018-03-28
PMA P040047S046 MERZ NORTH AMERICA, INC	Coaptite Injectable Implant	2018-03-28
PMA P050052S102 MERZ NORTH AMERICA, INC	Radiesse Lidocaine Dermal Filler	2018-02-12
PMA P050037S086 MERZ NORTH AMERICA, INC	Radiessee Injectable Implant	2018-02-12
PMA P040047S049 MERZ NORTH AMERICA, INC	Coaptite	2018-02-12
PMA P050052S092 MERZ NORTH AMERICA, INC	RADIESSE Lidocaine Dermal Filler	2018-01-02
PMA P050037S078 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2018-01-02
PMA P050052S099 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine Dermal Filler	2017-11-30
PMA P050037S083 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2017-11-30
PMA P040047S047 MERZ NORTH AMERICA, INC	COAPTITE Injectable Implant	2017-11-30
PMN K172689 Merz North America, Inc.	DESCRIBE PFD Patch	2017-11-29
PMA P050052S100 MERZ NORTH AMERICA, INC	Radiesse (+) Lidocaine Dermal Filler	2017-11-21
PMA P050037S084 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2017-11-21
PMA P050052S096 MERZ NORTH AMERICA, INC	Radiesse Injectable Implant	2017-09-18
PMA P050052S097 MERZ NORTH AMERICA, INC	Radiesse (+) Lidocaine Injectable Implant	2017-08-29
PMA P050052S094 MERZ NORTH AMERICA, INC	RADIESSE (+) Lidocaine Derma Filler	2017-06-27
PMA P050037S080 MERZ NORTH AMERICA, INC	RADIESSE Injectable Implant	2017-06-27
NDC 46783-175 Merz North America, Inc.	Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30	2015-05-18
NDC 46783-173 Merz North America, Inc.	Micro Day Rejuvenating Broad-spectrum Sunscreen SPF 30	2015-03-23
PMN P090016 | LMH Merz North America, Inc.	Belotero Balance Dermal Filler	2011-12-14
NDC 46783-165 Merz North America, Inc.	Xeomin	2011-08-01
NDC 46783-161 Merz North America, Inc.	Xeomin	2011-08-01
NDC 46783-160 Merz North America, Inc.	Xeomin	2011-08-01
NDC 46783-002 Merz North America, Inc.	Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30	2011-04-01
KDD Merz North America, Inc.	Cellfina System Prep Pack - CP1	2011-02-24
OJV Merz North America, Inc.	Accessory Kit	2010-11-02
NDC 46783-221 Merz North America, Inc	Asclera	2010-06-01
NDC 46783-121 Merz North America, Inc	Asclera	2010-06-01
PMN P050037 | LMH Merz North America, Inc.	Radiesse Injectable Implant	2007-12-17
PMN P050037 | LMH Merz North America, Inc.	Radiesse Injectable Implant	2007-12-17
PMN K060815 | MIX Merz North America, Inc.	Prolaryn Gel Injectable Implant	2007-12-17
PMN K060815 | MIX Merz North America, Inc.	Prolaryn Gel Injectable Implant	2007-12-17
PMN P050052 | PKY Merz North America, Inc.	Radiesse? (+)	2007-12-04
PMN P050052 | PKY Merz North America, Inc.	Radiesse? (+)	2007-12-04
PMN P050052 | PKY Merz North America, Inc.	Radiesse Injectable Implant	2007-12-04
PMN P050052 | PKY Merz North America, Inc.	Radiesse Injectable Implant	2007-12-04
PMN P050052 | LMH Merz North America, Inc.	Radiesse? (+)	2007-12-04
PMN P050052 | LMH Merz North America, Inc.	Radiesse? (+)	2007-12-04
PMN P050052 | LMH Merz North America, Inc.	Radiesse Injectable Implant	2007-12-04
PMN P050052 | LMH Merz North America, Inc.	Radiesse Injectable Implant	2007-12-04
PMN P040047 | LNM Merz North America, Inc.	Coaptite Injectable Implant	2007-12-04
PMN P040047 | LNM Merz North America, Inc.	Coaptite Injectable Implant	2007-12-04
PMN K013243 | KHJ Merz North America, Inc.	Prolaryn Plus Injectable Implant	2007-12-04
PMN K013243 | KHJ Merz North America, Inc.	Prolaryn Plus Injectable Implant	2007-12-04
GAA Merz North America, Inc.	Rigid Injection Needle	2003-08-05
GAA Merz North America, Inc.	Rigid Injection Needle	2003-08-05

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• Merz Pharma GmbH & Co. KGaA
• Chemische Fabrik Kreussler & Co. GmbH

Related Finance Registrations

NCAGE Code	74QG8	MERZ NORTH AMERICA, INC.
CAGE Code	74QG8	MERZ NORTH AMERICA, INC.
S.A.M. Registration	74QG8 [137113929]	MERZ NORTH AMERICA, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090219018	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER H.S.CODE 3923 3010	44 PCS
2020081362698	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER H.S.CODE 3923 3010	44 PCS
2020073055115	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER H.S.CODE 3923 3010	33 PCS
2020072851992	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	XEOMIN VIAL / MEDICAL EQUIPMENT	586 CTN
2020072851992	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	XEOMIN VIAL / MEDICAL EQUIPMENT	586 CTN
2020072357226	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER H.S.CODES 3923 3010 8424 8970	33 PCS
2020071746266	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER H.S.CODES 3923 3010 8424 8970	33 PCS
2020070159401	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	AIRLESS DIEPENSER H.S.CODE 39233010 84248970	33 PCS
2020061941109	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 3010	61 PCS
2020061941109	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 3010	61 PCS
2020061941109	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CLOSURE AIRLESS DISPENSER BASE AIRLESS DISPENSER H.S.CODES 8424 8970 / 3923 3010	61 PCS