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Synthetic Non-woven Surgical Gown
EUDAMEDClass I (EU MDR)
Ref 8918890CModel SMMS Standard Surgical Gown
Identity
- Device Name
- Synthetic Non-woven Surgical Gown EUDAMED
- Model / Reference
- SMMS Standard Surgical Gown EUDAMED8918890C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327047164 EUDAMED
- Basic UDI-DI
- 694109403808F6 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Synthetic Non-woven Surgical Gown 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 | 694109403808F6 | 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 a7067e52-a1ab-4d25-ab7d-d8d5a7a99c10 61 fields · synced Jul 13, 2026