Medical Gown
by Safeway Industry Healthcare 2 variants
Ref Gown
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697460179051002V | Date21 Aug 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Gown
- Model / Reference
- Gown
- Primary DI / UDI-DI
- 06974601790223, 06974601790186, 06974601790674, 06974601790131, 06974601790179, 06974601790162, 06974601790155, 06974601790148
- Basic UDI-DI
- 697460179051002V
- Unit of Use DI
- 06974601790667
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000001568
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Safeway Industry Healthcare
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