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Creatine Kinase Isoenzyme Assay Kit (Immunosuppressive Method)

EUDAMED

Class IVD General (EU MDR)

Ref DTSH040211Model R1: 80mL×4; R2: 80mL×1Ref DTSH040210Model R1: 60mL×4; R2: 60mL×1Ref DTSH040206Model R1: 40mL×1; R2: 10mL×1

by Da Te Bioengineering Technology Co., LTD.

Identity

Device Name
Creatine Kinase Isoenzyme Assay Kit (Immunosuppressive Method) EUDAMED
Model / Reference
R1: 80mL×4; R2: 80mL×1 EUDAMED
DTSH040211 EUDAMED
R1: 60mL×4; R2: 60mL×1 EUDAMED
DTSH040210 EUDAMED
R1: 40mL×1; R2: 10mL×1 EUDAMED
DTSH040206 EUDAMED

Identifiers

Primary DI / UDI-DI
06975225461742 EUDAMED
06975225461735 EUDAMED
06975225461681 EUDAMED
Basic UDI-DI
B-06975225461742 EUDAMED
B-06975225461735 EUDAMED
B-06975225461681 EUDAMED
EMDN Code
W01010115 CREATINE KINASE ISOENZYMES 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 Isoenzyme Assay Kit (Immunosuppressive 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

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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 (3)

  • EUDAMED bcaaff5d-6ada-49ae-93f2-462c7e58e550 61 fields · synced Jul 25, 2026
  • EUDAMED 8c1596c4-ac5f-4d0f-88db-5e4f4863c9de 61 fields · synced May 18, 2026
  • EUDAMED d1e393e0-ea13-4a4d-8cc9-601e52d44739 61 fields · synced May 18, 2026