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CreatineKinase-MB Controls
EUDAMEDClass IVD General (EU MDR)
Ref 1040491000Model CK-MB Control 1: 1 × 2 mL, CK-MB Control 2: 1 × 2 mLRef 1040492000Model CK-MB Control 1: 2 × 2 mL, CK-MB Control 2: 2 × 2 mL
Identity
- Device Name
- CreatineKinase-MB Controls EUDAMED
- Model / Reference
- CK-MB Control 1: 1 × 2 mL, CK-MB Control 2: 1 × 2 mL EUDAMED1040491000 EUDAMEDCK-MB Control 1: 2 × 2 mL, CK-MB Control 2: 2 × 2 mL EUDAMED1040492000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090500430 EUDAMED06975090501437 EUDAMED
- Basic UDI-DI
- B-06975090500430 EUDAMEDB-06975090501437 EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
CreatineKinase-MB Controls by Accucise Diagnostics Inc. — 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-06975090500430 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 74a5563f-91c0-47de-a7be-68150b60b91d 61 fields · synced Jul 28, 2026
- EUDAMED 8f12f02c-0a05-47a3-a814-a770ba0ae2dd 61 fields · synced May 16, 2026