Identity
- Device Name
- Nano coulomb H2 sensor EUDAMED
- Model / Reference
- SV-eH2-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971022540222 EUDAMED
- Basic UDI-DI
- 6971022SUNVOU011ZR EUDAMED
- EMDN Code
- W0101070299 SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Nano coulomb H2 sensor by Sunvou Medical Electronics Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6971022SUNVOU011ZR | Class A | Active |
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Manufacturer
- Manufacturer
- Sunvou Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004543
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 7206f4bb-e6d8-49d4-a58d-e82790bb260c 61 fields · synced Jun 19, 2026