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Polyurethane Foam Dressing
EUDAMEDClass IIa (EU MDR)
Ref F01100120Model Type F01
Identity
- Trade Name
- Polyurethane Foam Dressing EUDAMED
- Device Name
- Polyurethane Foam Dressing EUDAMED
- Model / Reference
- Type F01 EUDAMEDF01100120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489893402 EUDAMED
- Basic UDI-DI
- 697548989XLF012K EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa 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
Polyurethane Foam Dressing by Shandong Shinrise Medical Supplies Co., Ltd. — Class IIa — 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 | 697548989XLF012K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 30adb930-c13c-46e4-8789-b54f641e074e 61 fields · synced Jun 19, 2026