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Myoglobin/CK-MB/Troponin I Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VCMC-436Model VCMC
Identity
- Trade Name
- Myoglobin/CK-MB/Troponin I Combo Rapid Test EUDAMED
- Device Name
- Myoglobin/CK-MB/Troponin I Combo Rapid Test EUDAMED
- Model / Reference
- VCMC-436 EUDAMEDVCMC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VCMC-436K8 EUDAMED06937339209306 EUDAMED
- Basic UDI-DI
- B-VCMC-436K8 EUDAMEDB-06937339209306 EUDAMED
- EMDN Code
- W0102160706 MULTIPLE CARDIAC MARKERS - RT & POC 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
Yes
EUDAMEDEUDAMED
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
Myoglobin/CK-MB/Troponin I Combo Rapid Test 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-VCMC-436K8 | 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 3c8bdbd1-85d3-43a7-bbca-c86b51371059 61 fields · synced Oct 7, 2026
- EUDAMED 79ed974c-b1e6-42e0-a7a8-2fdbb5a16d7f 61 fields · synced Jul 9, 2026