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POLTX_Fiber
EUDAMEDClass IIb (EU MDR)
Ref 206041005Model Fiber_20Ref 206023005Ref 206043005
Identity
- Trade Name
- POLTX_Fiber EUDAMED
- Device Name
- POLTX_Fiber 200 gsm (Pad), 5x5 cm EUDAMED
- Model / Reference
- Fiber_20 EUDAMED206041005 EUDAMED206023005 EUDAMED206043005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640328070076 EUDAMED07640328070106 EUDAMED07640328070090 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 (3)
- EUDAMED 077e1d4d-f967-4f27-a052-c7980b7e9c32 61 fields · synced Aug 1, 2026
- EUDAMED a5f1f62b-dedd-4ecd-9904-8ae555d0753a 61 fields · synced May 18, 2026
- EUDAMED 67e30bff-52e3-4aa7-8798-0aac247d3c81 61 fields · synced May 19, 2026