← Back to catalogue
VivaChek Eco Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref VGC01-021Model VGC01Ref VIC
Identity
- Trade Name
- VivaChek Eco Control Solution EUDAMEDControl EUDAMED
- Device Name
- VivaChek Eco Control Solution EUDAMEDControl EUDAMED
- Model / Reference
- VGC01 EUDAMEDVGC01-021 EUDAMEDVIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339203472 EUDAMED06937339210647 EUDAMED
- Basic UDI-DI
- B-06937339203472 EUDAMEDB-06937339210647 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaChek Eco Control Solution by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — 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-06937339203472 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4f9dc857-64f1-48c7-abb8-0b7a9a9d48cd 61 fields · synced Oct 6, 2026
- EUDAMED f9e80d6f-e5b6-4189-8560-3150c2ca5f0c 61 fields · synced Jul 9, 2026