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Creatine Kinase-MB Isoenzyme Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref D002Model 125T
Identity
- Device Name
- Creatine Kinase-MB Isoenzyme Assay Kit EUDAMED
- Model / Reference
- 125T EUDAMEDD002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838801638 EUDAMED
- Basic UDI-DI
- B-06975838801638 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Creatine Kinase-MB Isoenzyme Assay Kit by Zhejiang Pushkang Biotechnology 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-06975838801638 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 724506a9-031c-4331-a104-dcf19cd9e648 61 fields · synced Jul 11, 2026