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Santecare Compresses Sterile Nonwoven
EUDAMEDClass I (EU MDR)
Ref 21036Model Synthetic Non-woven Swabs without X-ray Detectable Element
Identity
- Trade Name
- Santecare Compresses Sterile Nonwoven EUDAMED
- Model / Reference
- Synthetic Non-woven Swabs without X-ray Detectable Element EUDAMED21036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327019253 EUDAMED
- Basic UDI-DI
- 694109405483FE EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I 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
Santecare Compresses Sterile Nonwoven by Winner Medical Co., Ltd. — Class I — 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 | 694109405483FE | Class I | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3613327d-cc09-4dd2-83b2-062ec3711413 61 fields · synced Jun 19, 2026