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VivaDiag Plus Hemoglobin Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref VOS01-011Model VOS01
Identity
- Trade Name
- VivaDiag Plus Hemoglobin Test Strips EUDAMEDHemoglobin Test Strips EUDAMED
- Device Name
- Hemoglobin Test Strips EUDAMED
- Model / Reference
- VOS01 EUDAMEDVOS01-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VOS01-01199 EUDAMED06937339206879 EUDAMED
- Basic UDI-DI
- B-VOS01-01199 EUDAMEDB-06937339206879 EUDAMED
- EMDN Code
- W0102070105 RETICULOCYTE HAEMOGLOBIN CONTENT EUDAMEDW0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaDiag Plus Hemoglobin Test Strips by VivaChek Biotech (Hangzhou) 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-VOS01-01199 | 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 (2)
- EUDAMED 08973649-8f5a-41c4-a489-df40c7297ff2 61 fields · synced Oct 6, 2026
- EUDAMED f5d218d9-60d0-4008-90d9-dc2e9a5f5ec4 61 fields · synced Jul 28, 2026