← Back to catalogue
Polyurethane Foam Dressing
EUDAMEDClass IIa (EU MDR)
Ref F04102102Model Type F04
Identity
- Trade Name
- Polyurethane Foam Dressing EUDAMED
- Device Name
- Polyurethane Foam Dressing EUDAMED
- Model / Reference
- Type F04 EUDAMEDF04102102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489893693 EUDAMED
- Basic UDI-DI
- 697548989XLF042R 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 | 697548989XLF042R | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 00615816-1762-42fd-baa8-368289bfa659 61 fields · synced Jun 18, 2026