Isolation Gown
by Shandong Tricol Marine Biological Technology Co., Ltd 3 variants
Ref XK-GLA
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 | Number697101355XK-GLAEN | Date31 Mar 2022 | 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- Withdrawn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
- Isolation Gown
- Model / Reference
- XK-GLA
- Primary DI / UDI-DI
- 06971013551121, 06971013551114, 06971013551145, 06971013551138, 06971013551084, 06971013551107, 06971013551091
- Basic UDI-DI
- 697101355XK-GLAEN
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000013184
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Shandong Tricol Marine Biological Technology 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