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Alginate Dressing
EUDAMEDClass IIa (EU MDR)
Ref A0125100Model Type A01Ref A017575Ref A026070Model Type A02Ref A015050Ref A0125200Ref A01100100Ref A047090Model Type A04Ref A02100120Ref A03100120Model Type A03Ref A044050Ref A02100100Ref A03100100
Identity
- Trade Name
- Alginate Dressing EUDAMEDAlginate Dressing EUDAMED
- Device Name
- Alginate Dressing EUDAMEDAlginate Dressing EUDAMED
- Model / Reference
- Type A01 EUDAMEDA0125100 EUDAMEDA017575 EUDAMEDType A02 EUDAMEDA026070 EUDAMEDA015050 EUDAMEDA0125200 EUDAMEDA01100100 EUDAMEDType A04 EUDAMEDA047090 EUDAMEDA02100120 EUDAMEDType A03 EUDAMEDA03100120 EUDAMEDA044050 EUDAMEDA02100100 EUDAMEDA03100100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489890449 EUDAMED06975489890647 EUDAMED06975489890654 EUDAMED06975489890524 EUDAMED06975489890500 EUDAMED06975489890005 EUDAMED06975489890746 EUDAMED06975489890012 EUDAMED06975489890029 EUDAMED06975489890722 EUDAMED06975489890661 EUDAMED06975489890708 EUDAMED
- Basic UDI-DI
- 697548989XLA01ZP EUDAMED697548989XLA02ZR EUDAMED697548989XLA04ZV EUDAMED697548989XLA03ZT EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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 | 697548989XLA01ZP | 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 (12)
- EUDAMED 9e03a03e-662f-4fd7-945e-2002da15628b 61 fields · synced Oct 6, 2026
- EUDAMED 119c8047-f610-4786-abe1-777958267d0c 61 fields · synced May 11, 2026
- EUDAMED aa59ae6e-89ee-4f03-bac0-cf0e226a4a18 61 fields · synced May 16, 2026
- EUDAMED af4ab7d7-e215-4f6f-8484-c2fe1707943d 61 fields · synced May 16, 2026
- EUDAMED fe7962d0-b74f-4934-8450-11d99dc12b2d 61 fields · synced May 17, 2026
- EUDAMED f726916f-92cb-49a8-abfa-9874ff6a0728 61 fields · synced May 17, 2026
- EUDAMED c80e2472-d6a0-4901-872a-13f776b11e7a 61 fields · synced May 17, 2026
- EUDAMED 4ecf89c4-a787-4f23-9216-a322a70fb5b9 61 fields · synced May 17, 2026
- EUDAMED a126a1c3-a7b6-4332-b1e8-b6d5edf0ff80 61 fields · synced May 18, 2026
- EUDAMED c088d926-24c5-49b8-8886-4858257f86a7 61 fields · synced May 18, 2026
- EUDAMED d229000f-5007-4a7d-a03a-9fd55976f0b0 61 fields · synced May 18, 2026
- EUDAMED c91197e0-e13a-42ac-80d4-42f11ed7a862 61 fields · synced May 19, 2026