Identity
- Device Name
- wellky smart bracelet EUDAMED
- Model / Reference
- V48 EUDAMEDAuxiliary supplies EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978501110488 EUDAMED
- Basic UDI-DI
- 697850111SOSUA EUDAMED
- EMDN Code
- Y215199 ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
wellky smart bracelet by Shenzhen Vjoy Car Electronics Limited — 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 | 697850111SOSUA | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Vjoy Car Electronics Limited
- EUDAMED SRN
- CN-MF-000047545
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (1)
- EUDAMED faf6fbf6-8b39-4f2c-86e1-873c722bfcdf 61 fields · synced Jul 30, 2026