Identity
- Trade Name
- Disposable Reinforced Surgical Gown EUDAMED
- Device Name
- Disposable Surgical Gown EUDAMED
- Model / Reference
- FJY0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973866550108 EUDAMED
- Basic UDI-DI
- 697386655FGSGRGXR EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Disposable Reinforced Surgical 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 | 697386655FGSGRGXR | 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 (1)
- EUDAMED f88394f5-44c3-4b7b-83e3-d7650bef6555 61 fields · synced Jun 18, 2026