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Creatine Kinase Reagent Kit（ifcc Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000759Model R1: 4x50mL, R2: 2x25mLRef 3000757Model R1: 2x60mL, R2: 2x15mLRef 3012235Model R1: 4x50mL, R2: 1x50mLRef 3023204Ref 3021611Ref 3016562
Identity
- Trade Name
- CREATINE KINASE REAGENT KIT（IFCC METHOD） EUDAMED
- Device Name
- CREATINE KINASE REAGENT KIT（IFCC METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 2x25mL EUDAMED3000759 EUDAMEDR1: 2x60mL, R2: 2x15mL EUDAMED3000757 EUDAMEDR1: 4x50mL, R2: 1x50mL EUDAMED3012235 EUDAMED3023204 EUDAMED3021611 EUDAMED3016562 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202257438 EUDAMED06942202260711 EUDAMED06942202260742 EUDAMED06942202213212 EUDAMED06925794592644 EUDAMED06942202260735 EUDAMED
- Basic UDI-DI
- B-06942202257438 EUDAMEDB-06942202260711 EUDAMEDB-06942202260742 EUDAMEDB-06942202213212 EUDAMEDB-06925794592644 EUDAMEDB-06942202260735 EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 Reagent Kit（ifcc Method） by Dirui Industrial 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-06942202257438 | 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 (6)
- EUDAMED 8d419afa-ad4a-4ae4-99a2-e4a15d7ba1fc 61 fields · synced Aug 3, 2026
- EUDAMED eadf54a0-7cd2-4eb4-8d12-33f95b4f86eb 61 fields · synced May 17, 2026
- EUDAMED 6af5ca60-cf31-477a-9c55-eaf924a76f20 61 fields · synced May 18, 2026
- EUDAMED 23591e47-e155-48b3-aae2-d7900cd0fae8 61 fields · synced Jul 11, 2026
- EUDAMED 2557f641-fa86-4324-83f0-a5f8a6850315 61 fields · synced Aug 2, 2026
- EUDAMED dd28b7fd-cc47-4f27-861a-a2abe0dfcb25 61 fields · synced Aug 3, 2026