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VivaChek Fad Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref VGC02-031Model VGC02
Identity
- Trade Name
- VivaChek Fad Control Solution EUDAMED
- Device Name
- VivaChek Fad Control Solution EUDAMED
- Model / Reference
- VGC02 EUDAMEDVGC02-031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339203489 EUDAMED
- Basic UDI-DI
- B-06937339203489 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaChek Fad 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-06937339203489 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3b51d71e-c35f-4404-9d41-8f4cd0b29371 61 fields · synced Oct 7, 2026