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Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader
EUDAMEDClass IVD General (EU MDR)
Ref CMC-W23F
Identity
- Device Name
- Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader EUDAMED
- Model / Reference
- CMC-W23F EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CMC-W23FBK EUDAMED
- Basic UDI-DI
- B-CMC-W23FBK EUDAMED
- EMDN Code
- W0102160799 CARDIAC MARKERS - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cardiac Marker Combo Rapid Test Device and Fluorescent Immunoassay Reader by Assure Tech. (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-CMC-W23FBK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b1dc593e-7e26-4256-9657-9459680f76c3 61 fields · synced Jul 11, 2026