Identity
- Trade Name
- Gel toe separator EUDAMED
- Device Name
- Gel toe separator EUDAMED
- Model / Reference
- 53mm*35mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976340077061 EUDAMED
- Basic UDI-DI
- 697634007007JJ EUDAMED
- EMDN Code
- M04010299 FIXING DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Gel toe separator by Dongguan Uni-Sole Sports Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697634007007JJ | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Uni-Sole Sports Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000034905
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED b769025e-e443-4068-9f84-ff17bf97d2c1 61 fields · synced Oct 5, 2026