Identity
- Trade Name
- HydroTac Transparent Comfort EUDAMED
- Model / Reference
- 3613 EUDAMED685050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052199743196 EUDAMED
- Basic UDI-DI
- 40495003613KU EUDAMED
- Unit of Use DI
- 04052199743189 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
HydroTac Transparent Comfort by Paul Hartmann Ag — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40495003613KU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Paul Hartmann Ag
- EUDAMED SRN
- DE-MF-000005861
Sources (1)
- EUDAMED a5d51996-8078-443d-89b4-d0a9a1b111b2 61 fields · synced Jul 25, 2026