Bandage
by Highgreen Medical Technology Co., Ltd.
Ref HGC01-WModel HGC01-W,HGC1.5-W ,HGC02-W,HGC03-W ,HGC04-W,HGC05-W,HGC06-W,HGC01-M, HGC1.5-M , HGC02-M, HGC03-M, HGC04-M, HGC05-M,HGC06-M,TB-01A, TB-01B, TB-02, TB-03, TB-04, TB-05, TB-06,GTB-02, etc
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 | Number697617729BEU01LV 06976177290008 | Date12 Sep 2024 | 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- Withdrawn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
- Bandage
- Model / Reference
- HGC01-W, HGC1.5-W, HGC02-W, HGC03-W, HGC04-W, HGC05-W, HGC06-W, HGC01-M, HGC1.5-M, HGC02-M, HGC03-M, HGC04-M, HGC05-M, HGC06-M, TB-01A, TB-01B, TB-02, TB-03, TB-04, TB-05, TB-06, GTB-02, etc
- Primary DI / UDI-DI
- 06976177290008
- Basic UDI-DI
- 697617729BEU01LV
- EMDN Code
- M0304010101 Elastic compression bandages, non-adhesive, low extensibility (<70%)
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044144
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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