Isolation Gown with Knitted Cuff
by Operating Theatre Medical (Zhijiang) Co., Ltd EUDAMED
Active
Ref 9002540, 9002541Model Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff
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- Withdrawn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
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Isolation gown for single use
- Model / Reference
- Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff, 9002540, 9002541
- Primary DI / UDI-DI
- 06976128075449, 06976128075456
- Basic UDI-DI
- 6976128075000B3
- Unit of Use DI
- 16976128075446, 16976128075453
- 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
See all devices from Operating Theatre Medical (Zhijiang) Co., Ltd →
Properties
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