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Creatine Kinase Assay Kit (DGKC Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH040109Model R1: 60mL×2; R2: 15mL×2Ref DTSH040105Model R1: 20mL×1; R2: 5mL×1Ref DTSH040106Model R1: 40mL×1; R2: 10mL×1Ref DTSH040110Model R1: 60mL×4; R2: 60mL×1
Identity
- Device Name
- Creatine Kinase Assay Kit (DGKC Method) EUDAMED
- Model / Reference
- R1: 60mL×2; R2: 15mL×2 EUDAMEDDTSH040109 EUDAMEDR1: 20mL×1; R2: 5mL×1 EUDAMEDDTSH040105 EUDAMEDR1: 40mL×1; R2: 10mL×1 EUDAMEDDTSH040106 EUDAMEDR1: 60mL×4; R2: 60mL×1 EUDAMEDDTSH040110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461636 EUDAMED06975225461599 EUDAMED06975225461605 EUDAMED06975225461650 EUDAMED
- Basic UDI-DI
- B-06975225461636 EUDAMEDB-06975225461599 EUDAMEDB-06975225461605 EUDAMEDB-06975225461650 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
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 Assay Kit (DGKC Method) by Da Te Bioengineering Technology 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-06975225461636 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 65e1d3c3-5a9d-436f-9f1c-0a0fe4232bf5 61 fields · synced Jul 30, 2026
- EUDAMED 1eb10c1d-26ee-4263-93a8-e441de41850e 61 fields · synced May 17, 2026
- EUDAMED be6c6450-f246-47f0-b4b7-32fa423faee7 61 fields · synced May 17, 2026
- EUDAMED cca97a5e-4bca-4916-95df-0eae45be191f 61 fields · synced May 19, 2026