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Creatine Kinase (CK) Kit (Rate Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.04.03.EC.01
by Zybio Inc.
Identity
- Device Name
- Creatine Kinase (CK) Kit (Rate Method) EUDAMED
- Model / Reference
- 01.09.04.03.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262865837 EUDAMED
- Basic UDI-DI
- B-06973262865837 EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 (CK) Kit (Rate Method) by Zybio 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-06973262865837 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3b635991-125a-4a0a-bbba-c33c450f7655 61 fields · synced Jun 18, 2026