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Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）
EUDAMEDClass IVD General (EU MDR)
Ref 3004690Model R1: 4x50mL, R2: 1x50mL, Calibration sample: 1x1mLRef 3000776Model Calibration sample: 1×1mLRef 3000772Model R1: 4x50mL, R2: 1x50mLRef 3000773Model R1: 2x60mL, R2: 2x15mLRef 3021554Model R1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mLRef 3021157Model R1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mL, Control: 2x1mLRef 3012234Ref 3021639Model R1: 4x50mL, R2: 2x25mL， Calibration sample: 1x1mL, Control: 2x1mLRef 3019348Model R1: 2L, R2: 500mL，Calibration sample: 10x1mL, Ref 3006725Model Control: 2×1mL
Identity
- Trade Name
- CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION） EUDAMEDCRETINE KINASE MB ISOENZYME REAGENT KIT EUDAMED
- Device Name
- CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION） EUDAMEDCRETINE KINASE MB ISOENZYME REAGENT KIT EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL, Calibration sample: 1x1mL EUDAMED3004690 EUDAMEDCalibration sample: 1×1mL EUDAMED3000776 EUDAMEDR1: 4x50mL, R2: 1x50mL EUDAMED3000772 EUDAMEDR1: 2x60mL, R2: 2x15mL EUDAMED3000773 EUDAMEDR1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mL EUDAMED3021554 EUDAMEDR1: 4x50mL, R2: 1x50mL， Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3021157 EUDAMED3012234 EUDAMEDR1: 4x50mL, R2: 2x25mL， Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3021639 EUDAMEDR1: 2L, R2: 500mL，Calibration sample: 10x1mL, EUDAMED3019348 EUDAMEDControl: 2×1mL EUDAMED3006725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247002 EUDAMED06942202261725 EUDAMED06942202247026 EUDAMED06942202260636 EUDAMED06925794592606 EUDAMED06942202260650 EUDAMED06942202260698 EUDAMED06925794592637 EUDAMED06925794581167 EUDAMED06942202261718 EUDAMED
- Basic UDI-DI
- B-06942202247002 EUDAMEDB-06942202261725 EUDAMEDB-06942202247026 EUDAMEDB-06942202260636 EUDAMEDB-06925794592606 EUDAMEDB-06942202260650 EUDAMEDB-06942202260698 EUDAMEDB-06925794592637 EUDAMEDB-06925794581167 EUDAMEDB-06942202261718 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-06942202247002 | 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 (10)
- EUDAMED 213df7ba-4e68-4629-9476-6e2f26853713 61 fields · synced Sep 17, 2026
- EUDAMED 08c2c81c-b7ca-4b12-96bd-7c9e3a81f79f 61 fields · synced May 17, 2026
- EUDAMED 94b787ae-2483-41a9-b504-87ca1e0a1181 61 fields · synced May 18, 2026
- EUDAMED 5c19fc06-119c-498b-8096-ba0b4b013296 61 fields · synced May 18, 2026
- EUDAMED 7869f595-b5ed-4dc2-a9a1-5b0be6841430 61 fields · synced Jun 20, 2026
- EUDAMED c498cdc8-d368-4b8b-822f-3ccd7da8952d 61 fields · synced Jul 9, 2026
- EUDAMED e0fa71ab-751a-41ce-a9c8-9523804a923d 61 fields · synced Jul 18, 2026
- EUDAMED 99ac288d-4b57-4f20-bc38-3f2a35ba463c 61 fields · synced Jul 19, 2026
- EUDAMED 4a22d41b-59bf-46c2-94bb-69a1c8edb0da 61 fields · synced Jul 29, 2026
- EUDAMED 95ea8ed7-71e2-432b-9b83-45061eed91df 61 fields · synced Sep 17, 2026