Identity
- Device Name
- cTnI/CK-MB/Myo Test Panel EUDAMED
- Model / Reference
- Ir082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697994388Ir0823QEM EUDAMED
- Basic UDI-DI
- B-697994388Ir0823QEM EUDAMED
- EMDN Code
- W0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
cTnI/CK-MB/Myo Test Panel by Kangsheng Information Technology (Hangzhou) Co. LTD — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-697994388Ir0823QEM | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- EUDAMED SRN
- CN-MF-000053775
- Authorised Representative
- Crealkraft GmbH DE-AR-000049943
Sources (1)
- EUDAMED 8acf8462-8fae-4d24-a6dc-11d445deaceb 61 fields · synced Jul 13, 2026