← Back to catalogue

Creatine Kinase (CK)Test Kit(IFCC)

EUDAMED

Class IVD General (EU MDR)

Ref R1:100mL×1 R2:25mL×1（708）Ref R1:48mL×2 R2:12mL×2（705）Ref R1:64mL×2 R2:16mL×2（701）Ref R1:48mL×2 R2:24mL×1（791）Ref R1:48mL×2 R2:24mL×1（792）Ref R1:20mL×4 R2:5mL×4（796）Ref R1:20mL×1 R2:5mL×1（702）Ref R1:48mL×2 R2:12mL×2（716）Ref R1:20mL×4 R2:5mL×4（709）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Creatine Kinase (CK)Test Kit(IFCC) EUDAMED
Device Name
Creatine Kinase (CK)Test Kit(IFCC) EUDAMED
Model / Reference
R1:100mL×1 R2:25mL×1（708） EUDAMED
R1:48mL×2 R2:12mL×2（705） EUDAMED
R1:64mL×2 R2:16mL×2（701） EUDAMED
R1:48mL×2 R2:24mL×1（791） EUDAMED
R1:48mL×2 R2:24mL×1（792） EUDAMED
R1:20mL×4 R2:5mL×4（796） EUDAMED
R1:20mL×1 R2:5mL×1（702） EUDAMED
R1:48mL×2 R2:12mL×2（716） EUDAMED
R1:20mL×4 R2:5mL×4（709） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674863571 EUDAMED
06971674863564 EUDAMED
06971674863526 EUDAMED
06971674863588 EUDAMED
06971674863595 EUDAMED
06971674863601 EUDAMED
06971674863540 EUDAMED
06971674863632 EUDAMED
06971674863533 EUDAMED
Basic UDI-DI
B-06971674863571 EUDAMED
B-06971674863564 EUDAMED
B-06971674863526 EUDAMED
B-06971674863588 EUDAMED
B-06971674863595 EUDAMED
B-06971674863601 EUDAMED
B-06971674863540 EUDAMED
B-06971674863632 EUDAMED
B-06971674863533 EUDAMED
EMDN Code
W01010113 CREATINE KINASE - TOTAL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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)Test Kit(IFCC) by Biobase Biodustry(Shandong) Co., Ltd. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (9)

  • EUDAMED 138296c0-07f1-4a1b-afb2-45af305c9c7d 61 fields · synced Oct 6, 2026
  • EUDAMED 868d0728-4fa1-4cb6-a489-42b941be5bba 61 fields · synced May 16, 2026
  • EUDAMED b5d7c31b-2440-4715-994a-2a58cf2a30cc 61 fields · synced May 16, 2026
  • EUDAMED 420bda98-0a0c-4a58-a40e-32bbfce3e5b4 61 fields · synced May 17, 2026
  • EUDAMED 98d0b4e0-15a6-4f08-88af-b7ff44929760 61 fields · synced May 17, 2026
  • EUDAMED 5be5212e-2216-44f1-910c-611e0e6a11c9 61 fields · synced May 18, 2026
  • EUDAMED 57cc8192-6515-4c25-9e35-d95764872d03 61 fields · synced May 18, 2026
  • EUDAMED 48763cb9-fc21-4c69-a1a7-ab39506f66c1 61 fields · synced May 18, 2026
  • EUDAMED c7fbbbd0-ece9-46fb-9122-828b490da6b9 61 fields · synced May 18, 2026