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hs-cTnI/ CK-MB/ MYO Combo Test Kit (Immunofluorescence Method)
EUDAMEDClass IVD General (EU MDR)
Ref W-IF-Cardio3-40Model 40 tests/kit
Identity
- Trade Name
- hs-cTnI/ CK-MB/ MYO Combo Test Kit (Immunofluorescence Method) EUDAMED
- Device Name
- hs-cTnI/ CK-MB/ MYO Combo Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 40 tests/kit EUDAMEDW-IF-Cardio3-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973720131788 EUDAMED
- Basic UDI-DI
- B-06973720131788 EUDAMED
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
hs-cTnI/ CK-MB/ MYO Combo Test Kit (Immunofluorescence Method) by Wuhan Easydiagnosis Biomedicine 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-06973720131788 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cf6beeb0-37cd-4bf9-b74b-930032c2f936 61 fields · synced Jun 20, 2026