Identity
- Trade Name
- Alginate Dressing EUDAMED
- Device Name
- Alginate Dressing EUDAMED
- Model / Reference
- Type A04 EUDAMEDA04100120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489890036 EUDAMED
- Basic UDI-DI
- 697548989XLA04ZV EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Alginate 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 | 697548989XLA04ZV | 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 64d741f8-4614-4eca-a5b6-98f91ae8a7c4 61 fields · synced Jun 19, 2026