Identity
- Device Name
- Isolation gown EUDAMED
- Model / Reference
- L EUDAMEDXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932141212704 EUDAMED06932141212711 EUDAMED
- Basic UDI-DI
- 697317895M65TH EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Dongguan Shin Yi Healthcare Products Factory — 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 | 697317895M65TH | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Shin Yi Healthcare Products Factory
- EUDAMED SRN
- CN-MF-000020805
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 68f2a21b-80d6-45dc-9378-70209b654a88 61 fields · synced Jul 20, 2026
- EUDAMED 54daefcf-4633-443c-9f17-f2e355925693 61 fields · synced May 19, 2026