Identity
- Trade Name
- POLTX_Fiber EUDAMED
- Device Name
- POLTX_Fiber 200 gsm (Pad), 5x5 cm EUDAMED
- Model / Reference
- Fiber_20 EUDAMED205131010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640328070038 EUDAMED
- Basic UDI-DI
- 764032807FIBER_20S6 EUDAMED
- EMDN Code
- M040404 CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES 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
POLTX_Fiber by Polaroid Therapeutics AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 764032807FIBER_20S6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Polaroid Therapeutics AG
- EUDAMED SRN
- CH-MF-000049447
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 6c3f5a04-6997-440e-adc4-b3e0cb5c51c9 61 fields · synced Jun 19, 2026