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Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）
EUDAMEDClass IVD General (EU MDR)
Ref 3016548Model R1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION） EUDAMED
- Device Name
- CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3016548 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260674 EUDAMED
- Basic UDI-DI
- B-06942202260674 EUDAMED
- EMDN Code
- W01010115 CREATINE KINASE ISOENZYMES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition） by Dirui Industrial 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-06942202260674 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0888c286-4cd5-4ba0-abb0-457958c259c5 61 fields · synced Jun 19, 2026