Identity
- Trade Name
- Patientenkittel EUDAMED
- Device Name
- 100% Cotton non-woven Patient Robe EUDAMED
- Model / Reference
- 604-009673 EUDAMED604-006627 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941094069249 EUDAMED16941094070627 EUDAMED
- Basic UDI-DI
- 694109404838FN EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Patientenkittel 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 | 694109404838FN | 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 (2)
- EUDAMED 00ba9203-6c0f-425b-941e-8af47696bc41 61 fields · synced Jul 20, 2026
- EUDAMED bf17df42-8490-4dd5-a534-0015deceb2f0 61 fields · synced May 17, 2026