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Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref CMA-435
Identity
- Trade Name
- Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette EUDAMED
- Device Name
- Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette EUDAMED
- Model / Reference
- CMA-435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983188715 EUDAMED
- Basic UDI-DI
- B-06936983188715 EUDAMED
- EMDN Code
- W0102160706 MULTIPLE CARDIAC MARKERS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette by Hangzhou Alltest Biotech.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-06936983188715 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 1731a09b-3ecf-4496-91dc-cd0b4c6d0c63 61 fields · synced Jun 19, 2026