← Back to catalogue
CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass IVD General (EU MDR)
Ref /Ref IF5005
Identity
- Trade Name
- CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- CK-MB/hs-cTnI/Myo Fast Test Kit (Immunofluorescence Assay) EUDAMEDCK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- / EUDAMEDIF5005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414702040 EUDAMED06954414792638 EUDAMED
- Basic UDI-DI
- B-06954414702040 EUDAMED695441470204GW EUDAMED
- EMDN Code
- W01021304,W01021306,W01021311 EUDAMEDW01021399 CARDIAC MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Romania EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414702040 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414702040 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 15a16c33-353c-456a-a627-a5a8f57d1afb 61 fields · synced Jul 25, 2026
- EUDAMED ab88fe15-c3c3-40d1-a480-4f315c83ea1f 61 fields · synced Jul 25, 2026