Isolation gown with knitted cuff
by Operating Theatre Medical (Zhijiang) Co., Ltd China EUDAMED
Ref I001430OTMModel Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff EMDN T0205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6976128075000B3 | Date19 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Isolation gown for single use
- Model / Reference
- Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff, I001430OTM
- Primary DI / UDI-DI
- 06976128075166
- Basic UDI-DI
- 6976128075000B3
- Unit of Use DI
- 16976128075163
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000038254
- Authorised representative
- mono-uso nv BE-AR-000001322
Other devices from Operating Theatre Medical (Zhijiang) Co., Ltd
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06976128075166|6976128075000B3