Disposable Isolation Gown
by Xianning Full Guard Medical Products Co., Ltd. EUDAMED
Active
Ref FGIS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697386655FGIGSL | Date18 Nov 2025 | 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- Withdrawn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
- Model / Reference
- FGIS
- Primary DI / UDI-DI
- 06973866556124
- Basic UDI-DI
- 697386655FGIGSL
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000013685
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Xianning Full Guard Medical Products Co., Ltd.
See all devices from Xianning Full Guard Medical Products 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