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Creatine kinase mb test (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref HGCL02Model Please see the IFU
Identity
- Trade Name
- Creatine kinase mb test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Creatine kinase mb test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700403084 EUDAMED
- Basic UDI-DI
- 697029753043L4 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Creatine kinase mb test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697029753043L4 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4cf416d2-c4a3-4ad2-8d41-fabfb0e05078 61 fields · synced Jul 8, 2026