Identity
- Trade Name
- Disposable Isolation Gown EUDAMED
- Device Name
- Disposable Isolation Gown EUDAMED
- Model / Reference
- 21131 EUDAMED21132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973866559811 EUDAMED06973866559828 EUDAMED
- Basic UDI-DI
- 697386655FGIGSL EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMEDT020499 SURGICAL GOWNS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Disposable Isolation Gown by Xianning Full Guard Medical Products 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 | 697386655FGIGSL | Class I | Active |
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Manufacturer
- Manufacturer
- Xianning Full Guard Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000013685
- Authorised Representative
- Zoustech S.L. ES-AR-000002008
Sources (2)
- EUDAMED fd30daaf-a2e4-489d-a39e-3f77c1acaa55 61 fields · synced Jul 18, 2026
- EUDAMED 6ca91b02-e5a8-429e-a3b3-5769c38e7948 61 fields · synced May 19, 2026