Identity
- Trade Name
- Disposable isolation gown EUDAMED
- Device Name
- Disposable Isolation gown EUDAMED
- Model / Reference
- 04G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26974181713326 EUDAMED
- Basic UDI-DI
- 69741817104GLU EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Huaxin Garment 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 | 69741817104GLU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xianning Huaxin Garment Co., Ltd
- EUDAMED SRN
- CN-MF-000008984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED bfbb7bce-edf0-4280-a3b3-5b458e3c4617 61 fields · synced Jun 18, 2026