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Nano coulomb breath analyzer
EUDAMEDClass IVD General (EU MDR)
Ref Sunvou-CA2122
Identity
- Device Name
- Nano coulomb breath analyzer EUDAMED
- Model / Reference
- Sunvou-CA2122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971022540062 EUDAMED
- Basic UDI-DI
- B-06971022540062 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
No
EUDAMED
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-06971022540062 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sunvou Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004543
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a9d55e19-58ff-4c65-840d-51e7f2f2b43b 61 fields · synced Jun 18, 2026