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Sterile Alginate Wound Dressing
EUDAMEDClass IIa (EU MDR)
Ref AF03Model Non-adhesive Dressing,Self-adhesive Dressing
Identity
- Trade Name
- Sterile Alginate Wound Dressing EUDAMED
- Device Name
- Sterile Alginate Wound Dressing EUDAMED
- Model / Reference
- Non-adhesive Dressing,Self-adhesive Dressing EUDAMEDAF03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934889081338 EUDAMED
- Basic UDI-DI
- 69348890SAWD01YL EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile Alginate Wound Dressing by Qingdao Bright Moon Biomedical Material 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 | 69348890SAWD01YL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qingdao Bright Moon Biomedical Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000021492
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED bf2bafdf-d08a-496f-90a0-215b497376f3 61 fields · synced May 23, 2026