Freudenberg Medical L L C

FDA Filings

This page includes the latest FDA filings for Freudenberg Medical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Freudenberg Medical L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)

Registration Number	1222140
FEI Number	1000121130
Name	FREUDENBERG MEDICAL, LLC
Owner & Operator	Freudenberg Medical MIS
Contact Address	2301 CENTENNIAL BLVD. -- Jeffersonville IN 47130 US
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	2301 Centennial Blvd Jeffersonville, IN 47130 US
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198

Registration Number	3011241266
FEI Number	3011241266
Name	Freudenberg Medical, SRL
Owner & Operator	Freudenberg Medical, LLC
Contact Address	1110 Mark Avenue Carpinteria CA 93013 US
US Agent	Belinda Jackson Freudenberg Medical, LLC 805 5765308 belinda.jackson@freudenbergmedical.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	Zona Franca Coyol Calle 4, Av. 0, Edificio B13.4 La Garita Alajuela, 20113 CR
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number	3012268721
FEI Number	3012268721
Name	Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen)
Owner & Operator	Freudenberg Medical, LLC
Contact Address	Freudenberg Medical, LLC 1110 Mark Avenue Carpinteria CA 93013 US
Official Correspondent	Belinda Jackson 1-805-5765308-x
US Agent	Belinda Jackson FREUDENBERG MEDICAL, LLC 805 5765308 805 5665381 belinda.jackson@freudenbergmedical.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	F1-3 of Block 2 and F1 of Block 8, Beiguang Industrial Park, Lia Shenzhen Guangdong, 518111 CN
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number	2025182
FEI Number	2025182
Name	Freudenberg Medical, LLC
Owner & Operator	Freudenberg Medical, LLC
Contact Address	Freudenberg Medical, LLC 1110 Mark Avenue Carpinteria CA 93013 US
Official Correspondent	Belinda Jackson 1-805-5765308-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	1110 Mark Ave CARPINTERIA, CA 93013 US
Establishment Type	Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility

Registration Number	3013312227
FEI Number	3013312227
Name	Freudenberg Medical, LLC
Owner & Operator	Freudenberg Medical, LLC
Contact Address	Freudenberg Medical, LLC 1110 Mark Avenue Carpinteria CA 93013 US
Official Correspondent	Belinda Jackson 1-805-5765308-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	92 Blackburn Center Gloucester, MA 01930 US
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number	2031897
FEI Number	3008581151
Name	Freudenberg Medical, LLC
Owner & Operator	Freudenberg Medical, LLC
Contact Address	Freudenberg Medical, LLC 1110 Mark Avenue Carpinteria CA 93013 US
Official Correspondent	Belinda Jackson 1-805-5765308-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	5050 Rivergrade Road Baldwin Park, CA 91706 US
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00848253003139 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253003122 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253003115 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253003092 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002606 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002408 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002385 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002378 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002361 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002354 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer®	2023-11-13
GUDID 00848253002347 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2023-11-13
GUDID 00850004312001 FREUDENBERG MEDICAL, LLC	EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING PN1007960-100	2021-06-23
GUDID 00848253003696 Freudenberg Medical, LLC	InHealth Technologies	2021-02-11
GUDID 00848253003689 Freudenberg Medical, LLC	InHealth Technologies	2021-02-11
GUDID 00848253003672 Freudenberg Medical, LLC	InHealth Technologies	2021-02-11
GUDID 00848253003665 Freudenberg Medical, LLC	InHealth Technologies	2021-02-11
GUDID 00848253002194 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002187 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002170 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002163 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002156 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002149 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002132 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002125 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002118 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002101 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00813307013082 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00813307013013 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2020-05-21
GUDID 00848253002996 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; ClassicFlow	2020-03-26
PMN K190473 \| OBI FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Navvus II Catheter	2020-01-29
GUDID 00850004312049 FREUDENBERG MEDICAL, LLC	Steerable Introducer Sheath 12F PN1008533-004	2020-01-21
PMN K071823 \| ODU Freudenberg Medical, LLC	Perma Facial Implant	2019-12-17
GUDID 00848253002620 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00848253001654 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00848253001623 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307013068 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307012580 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307012573 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307012566 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307012559 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307011781 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; HumidiFilter	2019-11-08
GUDID 00813307011606 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307011590 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307011057 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307011040 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307011033 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307011026 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307011019 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307011002 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307010999 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307010982 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Classic	2019-11-08
GUDID 00813307010524 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010517 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010500 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010494 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010487 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010470 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010463 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010456 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010371 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010364 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010357 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010340 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010333 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010326 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010319 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010302 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010296 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010289 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010272 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010265 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010227 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010210 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010203 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010197 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010180 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010173 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010166 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010159 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010142 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010135 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010128 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010111 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010104 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010098 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010081 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010074 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010067 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010050 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010043 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010036 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010029 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010012 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00813307010005 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer	2019-11-08
GUDID 00850004312032 FREUDENBERG MEDICAL, LLC	Steerable Introducer Sheath 8.5F Large Curl PN1008533-003	2019-11-04
GUDID 00850004312025 FREUDENBERG MEDICAL, LLC	Steerable Introducer Sheath 8.5F Medium Curl PN1008533-002	2019-11-04
GUDID 00850004312018 FREUDENBERG MEDICAL, LLC	Steerable Introducer Sheath 8.5F Small Curl PN1008533-001	2019-11-04
PMN K192422 \| DRA FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Steerable Introducer Sheath 12F	2019-10-11
PMN K192422 \| DRA FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Steerable Introducer 12F	2019-10-11
PMN K191190 \| DYB FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Steerable Introducer Sheath 8.5F	2019-10-11
PMN K191190 \| DYB FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Steerable Introducer 8.5F	2019-10-11
PMN K192422 Freudenberg Medical LLC	Steerable Introducer 12F	2019-10-04
GUDID 00848253003627 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Accufit	2019-09-19
GUDID 00848253003610 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Accufit	2019-09-19
GUDID 00848253003603 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Accufit	2019-09-19
GUDID 00848253003597 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Hydrofit	2019-09-19
GUDID 00848253003580 Freudenberg Medical, LLC	InHealth Technologies; Blom-Singer; Hydrofit	2019-09-19
PMN K191190 Freudenberg Medical LLC	Steerable Introducer	2019-08-01
PMN K190628 \| DYB FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	FlexSeal Introducer Sheath with Hydrophilic Coating	2019-06-17
PMN K152586 \| NEU FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Beacon Fine Needle Fiducial System	2016-07-19
PMN K152586 \| FCG FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Beacon Fine Needle Fiducial System	2016-07-19
PMN K152069 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Nuance Nephrostomy Drainage Catheter	2015-12-18
PMN K152069 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Believe Biliary Drainage Catheter	2015-12-18
PMN K152069 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Array Multipurpose Drainage Catheter	2015-12-18
PMN K150187 \| PDU FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	ELITECROSS? Support Catheter	2015-08-08
PMN K142198 \| NEU FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	BNX Fine Needle Aspiration System	2014-12-16
PMN K142198 \| FCG FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	BNX Fine Needle Aspiration System	2014-12-16
PMN K141894 \| FCG FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	SharkCore Fine Needle Biopsy System	2014-12-16
PMN K133008 \| FCG FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	BNX Fine Needle Aspiration System	2014-12-16
PMN K800563 \| EWL Freudenberg Medical, LLC	Blom-Singer Duckbill Voice Prosthesis	2014-11-25
EPE Freudenberg Medical, LLC	Blom-Singer Cleaning Brush	2014-11-25
PMN K132474 \| OBI FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Rapid Exchange (RXi) System and Navvus Catheter	2014-02-17
PMN K132474 \| DXO FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Rapid Exchange (RXi) System and Navvus Catheter	2014-02-17
PMN K111315 \| LJE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Drainage Catheter	2012-11-28
PMN K111315 \| GBX FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Drainage Catheter	2012-11-28
PMN K111315 \| GBO FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Drainage Catheter	2012-11-28
PMN K111315 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Drainage Catheter	2012-11-28
PMN K103353 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Drainage Catheter	2012-11-28
PMN K093392 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Nephrostomy Drainage Catheter	2012-11-28
PMN K093392 \| FGE FREUDENBERG MEDICAL, LLC [Freudenberg Medical MIS]	Exodus Multipurpose Drainage Catheter	2012-11-28
KBE Freudenberg Medical, LLC	KATZ EXTRACTOR	2004-07-29

Related Finance Registrations

NCAGE Code	0RET8	FREUDENBERG MEDICAL, LLC!DBA HELIX MEDICAL!DIV INHEALTH TECHNOLOGIES
CAGE Code	0RET8	FREUDENBERG MEDICAL, LLC HELIX MEDICAL INHEALTH TECHNOLOGIES
S.A.M. Registration	0RET8 [120981337]	FREUDENBERG MEDICAL, LLC HELIX MEDICAL

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018091865544	Yantian,China (Mainland) -> Los Angeles, California	TRAY, SHIPPING	94 PKG