Toe Gel Sleeve
by Dongguan Uni-Sole Sports Technology Co., Ltd. 6 variants
Ref 150mm*25mm
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 | Number697634007006JG 06976340076033 | Date1 May 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- Withdrawn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
- Model / Reference
- 150mm*25mm
- Primary DI / UDI-DI
- 06976340076033
- Basic UDI-DI
- 697634007006JG
- EMDN Code
- M04010299 Fixing dressings - other
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000034905
- Authorised representative
- Everbiz GmbH DE-AR-000008964
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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