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Isolation Gown\ Protective Clothing
EUDAMEDClass I (EU MDR)
Ref C301\ C302\ C303\ C307Model C301 \ C302 \ C303 \ C304
Identity
- Trade Name
- Isolation Gown\ Protective Clothing EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- C301 \ C302 \ C303 \ C304 EUDAMEDC301\ C302\ C303\ C307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925923780355 EUDAMED
- Basic UDI-DI
- 69259237C302MY EUDAMED
- Direct Marketing DI
- 06925923780355 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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\ Protective Clothing by Hynaut Health Technology 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 | 69259237C302MY | Class I | Active |
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Manufacturer
- Manufacturer
- Hynaut Health Technology Co., LTD
- EUDAMED SRN
- CN-MF-000026762
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 306bafef-fc85-4a68-bd10-6a426ee0ef08 61 fields · synced Jun 18, 2026