Identity
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- S/M/L/XL/XXL/XXXL EUDAMEDMDN1214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975117817107 EUDAMED
- Basic UDI-DI
- 697511781XRIG10735 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Iceland 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
Isolation Gown by Xiantao Xingrong Protective 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 | 697511781XRIG10735 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Xingrong Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000020687
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 9d2d0630-2238-4819-ace6-11436199276e 61 fields · synced Jun 19, 2026