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Sign in to claim this brandPaul Hartmann Corp.
US
Last updated May 23, 2026
What Paul Hartmann Corp. makes
Paul Hartmann Corp. manufactures a range of wound care and skin protection products, including hydrophilic-gel dressings for exudate absorption, adhesive bandages, semi-permeable film dressings, wound hydrogels, nonadherent wound dressings, and non-adhesive retention bandages. Their portfolio also covers pressure bandages, silicone-based dressings, and skin adhesive tapes for fixation, with some items designed for sterile use. Examples include transparent film dressings, silicone-coated gauzes, and latex-free adhesive tapes for secure wound coverage.
The company’s products are classified under FDA categories, including Class I and Unclassified (U) devices, with regulatory records maintained in the FDA’s 510(k) and UDI databases. These items are intended for use in the United States, where compliance with FDA requirements governs their distribution and labeling.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Paul Hartmann Corp. manufacture?
Paul Hartmann Corp. specializes in wound care and skin protection products. Their portfolio includes exudate-absorbent dressings like hydrophilic-gel types, adhesive bandages, semi-permeable film dressings, wound hydrogels, nonadherent wound dressings, and non-adhesive retention bandages. They also produce pressure bandages, silicone-based dressings (e.g., silicone-coated gauzes), and skin adhesive tapes for fixation. Many of these products are designed for sterile use, ensuring compatibility with clinical environments.
Where is Paul Hartmann Corp. based, and what regulatory regions do their devices serve?
Paul Hartmann Corp. is based in the United States. Their devices are primarily intended for use in the U.S. market, where they must comply with FDA regulations. The company’s products are classified under FDA categories, including Class I and Unclassified (U) devices, and their regulatory records are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases.
Which regulatory registries list Paul Hartmann Corp.’s devices?
Paul Hartmann Corp.’s devices are documented in the FDA’s 510(k) premarket notification database and the UDI (Unique Device Identifier) system. These registries track regulatory submissions and compliance for medical devices in the U.S., ensuring transparency for healthcare providers and regulators.
How are Paul Hartmann Corp.’s devices classified under FDA regulations?
Paul Hartmann Corp.’s devices fall under two primary FDA classifications: Class I (generally low-risk devices requiring general controls) and Unclassified (U) (devices not yet assigned a risk class but still subject to FDA oversight). The classification depends on factors like intended use, risk level, and regulatory history, as outlined in the FDA’s device classification system.
What distinguishes Paul Hartmann Corp.’s wound care products from other manufacturers?
Paul Hartmann Corp. focuses on a diverse range of wound care solutions, including sterile and non-sterile options, silicone-based dressings for sensitive skin, and latex-free adhesive tapes. Their portfolio emphasizes versatility—from exudate management with hydrophilic-gel dressings to secure fixation with skin adhesive tapes—while adhering to FDA compliance for U.S. distribution. Examples like transparent film dressings and silicone-coated gauzes highlight their specialization in both protective and therapeutic wound coverage.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (122)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HydroTac transp.comf. 12, 5x12, 5cm st P10 | 685921 HydroTac transp.comf. 12,5x12,5cm st P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone 20x20 cm P10 | 413814 Zetuvit Plus Silicone 20x20 cm P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone 8x8cm P10 | 413114 Zetuvit Plus Silicone 8x8cm P10 | FDA UDI | Class I | Active |
| Hydrofilm 6x7cm st P100 C10 | 685756 Hydrofilm 6x7cm st P100 C10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 12, 5x12, 5cm | 413902 Zetuvit Plus Silicone Border 12,5x12,5cm | FDA UDI | Class I | Active |
| Hydrofilm 10x12, 5cm sterile P100 | 970003 Hydrofilm 10x12,5cm sterile P100 | FDA UDI | Class I | Active |
| Omnifix silicone, 10cmx5m, P1 | 900001 Omnifix silicone, 10cmx5m, P1 | FDA UDI | Class I | Active |
| Zetuvit Plus 25x20 P10 | 413113 Zetuvit Plus 25x20 P10 | FDA UDI | Class I | Active |
| Zetuvit Plus 10x10 P10 | 413110 Zetuvit Plus 10x10 P10 | FDA UDI | Class I | Active |
| Hydrofilm Plus 9x10cm st P5 C20 | 685772 Hydrofilm Plus 9x10cm st P5 C20 | FDA UDI | Class I | Active |
| Hydrofilm 15x20cm sterile P10 | 970006 Hydrofilm 15x20cm sterile P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 12, 5x12, 5cm | 413120 Zetuvit Plus Silicone Border 12,5x12,5cm | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone 10x20cm P10 | 413116 Zetuvit Plus Silicone 10x20cm P10 | FDA UDI | Class I | Active |
| Cosmopor Steril 20x10cm P25 C12 | 900812 Cosmopor Steril 20x10cm P25 C12 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border Sacr 18x18 | 413906 Zetuvit Plus Silicone Border Sacr 18x18 | FDA UDI | Class I | Active |
| Omnifix Elastic 15cm x 10m P1 C24 | 900604 Omnifix Elastic 15cm x 10m P1 C24 | FDA UDI | Class I | Active |
| Hydrofilm Plus 9x15cm st P25 C10 | 685775 Hydrofilm Plus 9x15cm st P25 C10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone 20x25cm P10 | 413815 Zetuvit Plus Silicone 20x25cm P10 | FDA UDI | Class I | Active |
| Zetuvit P10t Plus Silicone 10x20c | 413813 Zetuvit P10t Plus Silicone 10x20c | FDA UDI | Class I | Active |
| Atrauman Silicone st 5x7cm P10 C10 | 499568 Atrauman Silicone st 5x7cm P10 C10 | FDA UDI | Class I | Active |
| Cosmopor silicone 7, 2x5cm P10 | 901106 Cosmopor silicone 7,2x5cm P10 | FDA UDI | Class I | Active |
| Atrauman Silicone st 10x20cm P10 C8 | 499564 Atrauman Silicone st 10x20cm P10 C8 | FDA UDI | Class I | Active |
| Omnifix Elastic 10cm x 10m P1 C36 | 900603 Omnifix Elastic 10cm x 10m P1 C36 | FDA UDI | Class I | Active |
| Atrauman Ag | 499607 Atrauman Ag USA st 10x10cm, P10 | FDA UDI | U | Active |
| Omnifix Elastic FR 5cm x 5m P1 12K | 900608 Omnifix Elastic FR 5cm x 5m P1 12K | FDA UDI | Class I | Active |
| Hydrofilm 10x12, 5cm sterile P10 | 970002 Hydrofilm 10x12,5cm sterile P10 | FDA UDI | Class I | Active |
| HydroTac transparent 10x20cm st P10 C6 | 685902 HydroTac transparent 10x20cm st P10 C6 | FDA UDI | Class I | Active |
| Atrauman Silicone st 20x30cm P5 C4 | 499565 Atrauman Silicone st 20x30cm P5 C4 | FDA UDI | Class I | Active |
| Hydrofilm Plus 9x10cm st P50 C10 | 685773 Hydrofilm Plus 9x10cm st P50 C10 | FDA UDI | Class I | Active |
| HydroTac transparent 5cmx7, 5cm st P10 | 685900 HydroTac transparent 5cmx7,5cm st P10 | FDA UDI | Class I | Active |
| HydroTac transparent 10cmx10cm st P10 | 685901 HydroTac transparent 10cmx10cm st P10 | FDA UDI | Class I | Active |
| Omnifix Elastic 10cm x 2m P1 C64 | 900601 Omnifix Elastic 10cm x 2m P1 C64 | FDA UDI | Class I | Active |
| HydroTac transparent comf. 8x8cm st P10 | 685920 HydroTac transparent comf. 8x8cm st P10 | FDA UDI | Class I | Active |
| Hydrofilm 15x20cm st P10 C10 | 685761 Hydrofilm 15x20cm st P10 C10 | FDA UDI | Class I | Active |
| Atrauman St 10x20cm P30 C5 | 499536 Atrauman St 10x20cm P30 C5 | FDA UDI | Class I | Active |
| Zetuvit Plus | 413739 Zetuvit Plus 20 x 60 cm P10 | FDA UDI | Class I | Active |
| Atrauman St 20x30cm P10 C3 | 499515 Atrauman St 20x30cm P10 C3 | FDA UDI | Class I | Active |
| HydroTac transp. comfort 8x8cm st P10 | 685925 HydroTac transp. comfort 8x8cm st P10 | FDA UDI | Class I | Active |
| Cosmopor transparent 9x15cm sterile P25 | 901055 Cosmopor transparent 9x15cm sterile P25 | FDA UDI | Class I | Active |
| HydroTac transparent 20x20cm steril P10 | 685908 HydroTac transparent 20x20cm steril P10 | FDA UDI | Class I | Active |
| Hydrofilm 10x15cm sterile P10 | 970004 Hydrofilm 10x15cm sterile P10 | FDA UDI | Class I | Active |
| Atrauman Ag | 499608 Atrauman Ag USA st 10x20cm, P10 | FDA UDI | U | Active |
| HydroTac transp. comf. 6, 5x10cm st P10 | 685923 HydroTac transp. comf. 6,5x10cm st P10 | FDA UDI | Class I | Active |
| Cosmopor Silicone Island Dressing 14” x 4” / 35cm x 10cm | 901110 Cosmopor Silicone Island Dressing 14” x 4” / 35cm x 10cm | FDA UDI | Class I | Active |
| Hydrofilm 6x7cm st P10 C20 | 685755 Hydrofilm 6x7cm st P10 C20 | FDA UDI | Class I | Active |
| Zetuvit Plus | 413729 Zetuvit Plus 6 x 6 cm P10 | FDA UDI | Class I | Active |
| Peha-Haft Latex Free 10cmx4m P1 C140 | 932444 Peha-Haft Latex Free 10cmx4m P1 C140 | FDA UDI | Class I | Active |
| Cosmopor Steril 10x10cm P25 | 900820 Cosmopor Steril 10x10cm P25 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 20x25cm P10 | 413123 Zetuvit Plus Silicone Border 20x25cm P10 | FDA UDI | Class I | Active |
| Hydrofilm 10x15cm sterile P50 | 970005 Hydrofilm 10x15cm sterile P50 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Paul Hartmann Sas LIEPVRE Haut-Rhin · FR FEI 3003111059