← Back to catalogue
Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013856Model 1×50 tests/kitRef 3008767Model 1×100 tests/kit
Identity
- Trade Name
- Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 tests/kit EUDAMED3013856 EUDAMED1×100 tests/kit EUDAMED3008767 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794519665 EUDAMED06925794511904 EUDAMED
- Basic UDI-DI
- B-06925794519665 EUDAMEDB-06925794511904 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 Detection Kit (Chemiluminescence Immunoassay) 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-06925794519665 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a4f3f206-391a-48fc-8481-f349381af07b 61 fields · synced Aug 4, 2026
- EUDAMED d10cf35e-a6b0-4a99-bf3c-32d84ccdc30f 61 fields · synced May 19, 2026