Paul Hartmann Ag

FDA Filings

This page includes the latest FDA filings for Paul Hartmann Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

GERMANYFRANKFURT STOCK EXCHANGEPHH2DUNS 315768788
FDA Registration(s)
Registration Number3003111059
FEI Number3003111059
NameDiane Marsilo
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address481 Lakeshore Parkway
Rock Hill, SC 29730 US
Establishment TypeManufacture Medical Device

Registration Number3002521238
FEI Number3002521238
NamePAUL HARTMANN AG
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressROBERT BOSCH STRABE 5
HERBRECHTINGEN Baden-Wurttemberg, 89542 DE
Establishment TypeManufacture Medical Device

Registration Number3004623655
FEI Number3004623655
NamePAUL HARTMANN AG
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGREGOR VON BRUCK RING 13
BRUCK Brandenburg, 14822 DE
Establishment TypeManufacture Medical Device

Registration Number3009080375
FEI Number3009080375
NamePAUL HARTMANN S.A.
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressP.I. Pla d en Boet II Carrasco i Formiguera, 48
Matar? Barcelona, E-08302 ES
Establishment TypeManufacture Medical Device

Registration Number3003096716
FEI Number3003096716
NameAusonia Montornes Plant - FPW
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAutopista A-7, Salida 13
Montornes del Valles Barcelona, 08170 ES
Establishment TypeManufacture Medical Device

Registration Number8010690
FEI Number2926
NameDiane Marsilo
Owner & OperatorPAUL HARTMANN AG
Contact Address481 Lakeshore Parkway --
Rock Hill SC 29730 US
Official Correspondent
  • Diane Marsilio
  • 001-803-9851120-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address481 Lakeshore Parkway
Rock Hill, SC 29730 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
PAUL HARTMANN AG
 Atrauman Ag 4996082025-03-27
PAUL HARTMANN AG
 Atrauman Ag 4996072025-03-27
PAUL HARTMANN AG
 Atrauman Ag 499606 2025-03-27
PAUL HARTMANN AG
 AC TAPE PLUS 2X5 72/CS 642100002024-01-24
PAUL HARTMANN AG
 Cosmopor transparent 5x7,2cm sterile P50 2023-05-25
PAUL HARTMANN AG
 Cosmopor transparent 5x7,2cm sterile P5 2023-05-25
PAUL HARTMANN AG
 Cosmopor transparent 9x10cm sterile P5 2023-05-25
PAUL HARTMANN AG
 Cosmopor transparent 9x10cm sterile P50 2023-05-25
PAUL HARTMANN AG
 Cosmopor transparent 9x15cm sterile P5 2023-05-25
PAUL HARTMANN AG
 Cosmopor transparent 9x15cm sterile P25 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 15x20cm sterile P10 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 10x15cm sterile P10 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 10x12,5cm sterile P10 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 10x12,5cm sterile P100 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 10x15cm sterile P50 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 20x30cm sterile P10 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 15x20cm sterile P50 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 6x7cm sterile P10 2023-05-25
PAUL HARTMANN AG
 Hydrofilm 6x7cm sterile New P100 2023-05-25
PAUL HARTMANN AG
 Proximel Silicon Border Dressing 2x2 10P 2023-05-18
PAUL HARTMANN AG
 Proximel Silicone Dressing SM HEEL 5/BX 2023-05-18
PAUL HARTMANN AG
 Hydrofilm Plus 9x15cm st P25 C10 2023-05-18
PAUL HARTMANN AG
 Atrauman St 10x20cm P30 C5 2023-05-18
PAUL HARTMANN AG
 ColActive Plus Powder Wound Filler 2021-09-06
PAUL HARTMANN AG
 ColActive Plus Powder Ag Wound Filler 2021-09-06
PAUL HARTMANN AG
 Eze-Band Basic Sterile 3x5 36/cs 2021-06-14
PAUL HARTMANN AG
 Eze-Band Basic Sterile 6x5 36/cs 2021-06-14
PAUL HARTMANN AG
 Eze-Band Basic Sterile 4x5 36/cs 2021-06-14
PAUL HARTMANN AG
 Eze-Band Basic Sterile 6x10 24/cs 2021-06-14
PAUL HARTMANN AG
 Eze-Band Basic Sterile 2x5 36/cs 2021-06-14
PAUL HARTMANN AG
 Zetuvit Plus 15x20 P10 2020-09-10
PAUL HARTMANN AG
 Zetuvit Plus 10x10 P10 2020-09-09
PAUL HARTMANN AG
 Proximel NB AG Silicone Dressing 6X6 2020-09-09
PAUL HARTMANN AG
 Proximel NB AG Silicone Dressing 8x8 2020-09-09
PAUL HARTMANN AG
 Proximel NB AG Silicone Dressing 4x4 2020-09-09
PAUL HARTMANN AG
 STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P 2020-09-09
PAUL HARTMANN AG
 Peha-Haft Latex Free 6cm x 4m P1 C140 2020-09-09
PAUL HARTMANN AG
 Peha-Haft Latex Free 4mx4cm P1 C280 >/3 2020-09-09
PAUL HARTMANN AG
 Peha-Haft Latex Free 10cmx4m P1 C140 2020-09-09
PAUL HARTMANN AG
 Peha-Haft Latex Free 8cm x 4m P1 C140 2020-09-09
PAUL HARTMANN AG
 Omnifix Elastic 15cm x 10m P1 C24 2020-09-09
PAUL HARTMANN AG
 Omnifix Elastic 10cm x 10m P1 C36 2020-09-09
PAUL HARTMANN AG
 Omnifix Elastic 5cm x 10m P1 C63 2020-09-09
PAUL HARTMANN AG
 Omnifix Elastic 10cm x 2m P1 C64 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 20x20cm steril P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 10x20cm steril P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 10x10cm steril P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comf. 6,5x10cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comf. 10x20cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comf.12,5x12,5cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comfort 8x8cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 5x7,5cm steril P10 2020-09-09
PAUL HARTMANN AG
 Zetuvit Plus 20x40 P10 2020-09-09
PAUL HARTMANN AG
 Atrauman Silicone st 5x7cm P10 C10 2020-09-09
PAUL HARTMANN AG
 Atrauman Silicone st 7,5x10cm P10 C4 2020-09-09
PAUL HARTMANN AG
 Atrauman Silicone st 10x20cm P10 C8 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 15x15cm P25 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 10x10cm P25 2020-09-09
PAUL HARTMANN AG
 Sorbalgon T 2gram 30cm P5 C10 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 35x10cm P25 C8 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 25x10cm P25 C8 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 20x10cm P25 C12 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 15x8cm P25 C14 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 10x8cm P25 C22 2020-09-09
PAUL HARTMANN AG
 Atrauman Silicone st 20x30cm P5 C4 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comf. 6,5x10cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp. comf. 10x20cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transp.comf. 12,5x12,5cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent comf. 8x8cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 20x20cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 10x20cm st P10 C6 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 10cmx10cm st P10 2020-09-09
PAUL HARTMANN AG
 HydroTac transparent 5cmx7,5cm st P10 2020-09-09
PAUL HARTMANN AG
 Atrauman st 10x10cm P10 C20 2020-09-09
PAUL HARTMANN AG
 Omnifix Elastic FR 5cm x 5m P1 12K 2020-09-09
PAUL HARTMANN AG
 Hydrofilm Plus 9x15cm st P5 C20 2020-09-09
PAUL HARTMANN AG
 Hydrofilm Plus 9x10cm st P50 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm Plus 9x10cm st P5 C20 2020-09-09
PAUL HARTMANN AG
 Hydrofilm Plus 5x7,2cm st P50 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm Plus 5x7,2cm st P5 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 20x30cm st P10 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 15x20cm st P50 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 15x20cm st P10 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 10x15cm st P50 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 10x15cm st P10 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 10x12,5cm st P100 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 10x12,5cm st P10 C20 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 6x7cm st P100 C10 2020-09-09
PAUL HARTMANN AG
 Hydrofilm 6x7cm st P10 C20 2020-09-09
PAUL HARTMANN AG
 Atrauman St 20x30cm P10 C3 2020-09-09
PAUL HARTMANN AG
 Atrauman St 7.5x10cm P10 C20 2020-09-09
PAUL HARTMANN AG
 Cosmopor Steril 7.2x5cm P50 C20 2020-09-09
PAUL HARTMANN AG
 Atrauman St 5x5cm P10 C40 2020-09-09
PAUL HARTMANN AG
 Peha-Haft 2.5cmx4m P8 C12 2020-09-09
PAUL HARTMANN AG
 COLACTIVE PLUS 7x7 10/BX 2020-09-09
PAUL HARTMANN AG
 COLACTIVE PLUS AG 7x7 10/BX 2020-09-09
PAUL HARTMANN AG
 ColActive Plus AG 4x4 300/cs 2020-09-09
PAUL HARTMANN AG
 ColActive Plus AG 2x2 600/cs 2020-09-09
PAUL HARTMANN AG
 ColActive Plus 4x4 2020-09-09
PAUL HARTMANN AG
 ColActive Plus 2x2 2020-09-09
Diane Marsilo [PAUL HARTMANN AG]
STERILUX GAUZE Bulky / Sponges2007-12-05
Diane Marsilo [PAUL HARTMANN AG]
ECONOLUX2007-12-05
Diane Marsilo [PAUL HARTMANN AG]
STERILUX X-RAY DETECTABLE2007-12-05
PAUL HARTMANN AG
Molimed Multiple Styles2007-04-02
PAUL HARTMANN AG
Molimed Multiple Styles2007-04-02
PAUL HARTMANN AG
Moliform Multiple Styles2007-04-02
PAUL HARTMANN AG
Moliform Multiple Styles2007-04-02
PAUL HARTMANN AG
Molicare Multiple Styles2007-04-02
PAUL HARTMANN AG
Molicare Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity, Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity, Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Super Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Super Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Extra Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Extra Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Compose Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Compose Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Complete Multiple Styles2007-04-02
PAUL HARTMANN AG
Dignity Complete Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Molimed Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Molimed Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Moliform Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Moliform Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Molicare Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Molicare Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity, Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity, Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Super Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Super Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Extra Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Extra Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Compose Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Compose Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Complete Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
Dignity Complete Multiple Styles2007-04-02
Diane Marsilo [PAUL HARTMANN AG]
PERMAFOAM2006-11-15
Diane Marsilo [PAUL HARTMANN AG]
Hydrofilm2006-11-15
Diane Marsilo [PAUL HARTMANN AG]
HydroTac2006-11-15
PAUL HARTMANN S.A. [PAUL HARTMANN AG]
FLEX-BAND AND OMNIFIX2006-11-15
PAUL HARTMANN S.A. [PAUL HARTMANN AG]
COSMOPORE2006-11-15
Diane Marsilo [PAUL HARTMANN AG]
FLEX-BAND AND OMNIFIX2006-11-15
Diane Marsilo [PAUL HARTMANN AG]
COSMOPORE2006-11-15

Related Finance Registrations
NCAGE CodeD0304PAUL HARTMANN AG
CAGE CodeD0304PAUL HARTMANN AG
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092941215Stadersand,Federal Republic of Germany -> Charleston, South CarolinaINCONTINENCE PRODUCTS1328 CTN
2020092326868Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020092326868Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020092326868Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020092155575Stadersand,Federal Republic of Germany -> Charleston, South CarolinaINCONTINENCE PRODUCTS1328 CTN
2020091488730Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020091488730Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020091488730Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT3596 CTN
2020091252438Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091252438Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091252438Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091184388Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091184388Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091184388Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091072178Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091072178Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020091072178Stadersand,Federal Republic of Germany -> New York, New YorkMEDICAL EQUIPMENT3596 CTN
2020090436012Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT1523 CTN
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