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Isolation Gown
EUDAMEDClass I (EU MDR)
Ref XLModel S,M,L,XL,XXL,XXXL,or customized
Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- S,M,L,XL,XXL,XXXL,or customized EUDAMEDXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974802482033 EUDAMED
- Basic UDI-DI
- 697480248IsolationGownJ2 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Hubei Yinshun Protective Equipment 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 | 697480248IsolationGownJ2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Yinshun Protective Equipment Co.LTD
- EUDAMED SRN
- CN-MF-000035206
- Authorised Representative
- AION CIRCUITS, LDA PT-AR-000044689
Sources (1)
- EUDAMED 03b834af-2907-430b-bf94-1342cd99e5a9 61 fields · synced Jun 18, 2026