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Nano coulomb breath analyzer
EUDAMEDClass IVD General (EU MDR)
Ref Sunvou-NA1108Ref Sunvou-DA7349Ref Sunvou-HA1101Ref Sunvou-TM2120
Identity
- Device Name
- Nano coulomb breath analyzer EUDAMED
- Model / Reference
- Sunvou-NA1108 EUDAMEDSunvou-DA7349 EUDAMEDSunvou-HA1101 EUDAMEDSunvou-TM2120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971022540710 EUDAMED06971022540604 EUDAMED06971022540581 EUDAMED06971022540147 EUDAMED
- Basic UDI-DI
- B-06971022540710 EUDAMEDB-06971022540604 EUDAMEDB-06971022540581 EUDAMEDB-06971022540147 EUDAMED
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Nano coulomb breath analyzer by Sunvou Medical Electronics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971022540710 | Class IVD General | 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 (4)
- EUDAMED 041c6aa6-fc26-4af8-9f40-cf3f022e38ea 61 fields · synced Jul 17, 2026
- EUDAMED 94c9ed6f-18d8-4ebd-8537-ab5e6603989c 61 fields · synced May 18, 2026
- EUDAMED 04fe0334-d801-40df-959f-1782d9647a03 61 fields · synced May 18, 2026
- EUDAMED 6677193c-0926-4fde-bbce-2df19d46d8d7 61 fields · synced May 18, 2026