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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 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zetuvit Plus Sil Bor 17, 5x17, 5cm P10 | 413121 Zetuvit Plus Sil Bor 17,5x17,5cm P10 | FDA UDI | Class I | Active |
| 10612553011647 | 34200000 | FDA UDI | Class I | Active |
| HydroTac transparent 20x20cm st P10 | 685903 HydroTac transparent 20x20cm st P10 | FDA UDI | Class I | Active |
| Hydrofilm 6x7cm sterile P10 | 970000 Hydrofilm 6x7cm sterile P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 15x25cm P10 | 413122 Zetuvit Plus Silicone Border 15x25cm P10 | FDA UDI | Class I | Active |
| Peha-Haft 2.5cmx4m P8 C12 | 932452 Peha-Haft 2.5cmx4m P8 C12 | FDA UDI | Class I | Active |
| Hydrofilm 10x12, 5cm st P100 C10 | 685758 Hydrofilm 10x12,5cm st P100 C10 | FDA UDI | Class I | Active |
| HydroTac transp. comf. 6, 5x10cm st P10 | 685928 HydroTac transp. comf. 6,5x10cm st P10 | FDA UDI | Class I | Active |
| Cosmopor Steril 35x10cm P25 C8 | 900816 Cosmopor Steril 35x10cm P25 C8 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 8x8cm | 413900 Zetuvit Plus Silicone Border 8x8cm | FDA UDI | Class I | Active |
| Cosmopor silicone 10x8cm P10 | 901107 Cosmopor silicone 10x8cm P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border 15x15cm | 413903 Zetuvit Plus Silicone Border 15x15cm | FDA UDI | Class I | Active |
| Cosmopor transparent 5x7, 2cm sterile P50 | 901051 Cosmopor transparent 5x7,2cm sterile P50 | FDA UDI | Class I | Active |
| Atrauman St 7.5x10cm P10 C20 | 499513 Atrauman St 7.5x10cm P10 C20 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone Border Sacr 23x23 | 413907 Zetuvit Plus Silicone Border Sacr 23x23 | FDA UDI | Class I | Active |
| Zetuvit Plus 15x20 P10 | 413112 Zetuvit Plus 15x20 P10 | FDA UDI | Class I | Active |
| Zetuvit Plus Silicone 12, 5x12, 5cm P10 | 413115 Zetuvit Plus Silicone 12,5x12,5cm P10 | FDA UDI | Class I | Active |
| Ria Panty Shields | K843401 | FDA 510(k) | Class I | Active |
| Molinea Incontinent Pad | K843404 | FDA 510(k) | Class I | Active |
| Molinea Panty | K843403 | FDA 510(k) | Class I | Active |
| Molinea Underpads | K843402 | FDA 510(k) | Class I | Active |
| Molicare | K843405 | FDA 510(k) | 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