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Synthetic Non-woven Surgical Gown
EUDAMEDClass I (EU MDR)
Ref 604-008845Model SMMS High Performance Surgical Gown
Identity
- Device Name
- Synthetic Non-woven Surgical Gown EUDAMED
- Model / Reference
- SMMS High Performance Surgical Gown EUDAMED604-008845 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941094051671 EUDAMED
- Basic UDI-DI
- 694109404512EM EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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 | 694109404512EM | 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 ed135c69-4d4f-4c5d-91d6-01726489aa7c 61 fields · synced Jul 29, 2026