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Hemoglobin Testing System Control Solution
EUDAMEDClass IVD General (EU MDR)
Ref VOC02-011Model VOC02
Identity
- Trade Name
- Hemoglobin Testing System Control Solution EUDAMED
- Device Name
- Hemoglobin Testing System Control Solution EUDAMED
- Model / Reference
- VOC02 EUDAMEDVOC02-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339207050 EUDAMED
- Basic UDI-DI
- B-06937339207050 EUDAMED
- EMDN Code
- W0103010606 HAEMATOLOGY CONTROLS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hemoglobin Testing System Control Solution by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06937339207050 | Class IVD General | 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 b0e74f15-bf99-4519-a7d2-2c9a32b409a2 61 fields · synced Jun 20, 2026