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Isolation Gown
EUDAMEDClass I (EU MDR)
Ref XXXLModel S,M,L,XL,XXL,XXXL,or customizedRef LRef XXLRef SRef M
Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- S,M,L,XL,XXL,XXXL,or customized EUDAMEDXXXL EUDAMEDL EUDAMEDXXL EUDAMEDS EUDAMEDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974802482057 EUDAMED06974802482026 EUDAMED06974802482040 EUDAMED06974802482002 EUDAMED06974802482019 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 (5)
- EUDAMED cc7010f6-8ca0-4fba-a208-78acb7eff338 61 fields · synced Oct 8, 2026
- EUDAMED a6a1b00c-8de4-4e4c-8da4-df43e97471a1 61 fields · synced May 17, 2026
- EUDAMED 0167ae94-2e5b-4737-a542-bb8b4d978b3a 61 fields · synced May 19, 2026
- EUDAMED fc422ab5-f47e-44b7-bdeb-eb61e8eda9a5 61 fields · synced May 19, 2026
- EUDAMED 6d1e3935-22c7-4279-a45a-b8415814aae4 61 fields · synced May 19, 2026