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Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

EUDAMED

Class IVD General (EU MDR)

Ref R1:20mL×1 R2:5mL×1（702）Ref R1:80mL×2 R2:20mL×2（706）Ref R1:48mL×2 R2:12mL×2（713）Ref R1:48mL×2 R2:12mL×2（705）Ref R1:100mL×1 R2:25mL×1（708）Ref Quality Control: 2mL×1（92104）Model Quality Control: 2mL×1（92104）Ref R1:40mL×4 R2:20mL×2（704）Ref R1:20mL×4 R2:5mL×4（709）Ref R1:48mL×2 R2:12mL×2（716）Ref R1:64mL×6 R2:48mL×2（795）Ref R1:20mL×4 R2:5mL×4（710）Ref R1:48mL×2 R2:24mL×1（792）Ref R1:48mL×2 R2:24mL×1（791）Ref R1:50ml×2 R2:25ml×1（793）Ref R1:20mL×4 R2:5mL×4（796）Ref R1:64mL×2 R2:16mL×2（794）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression) EUDAMED
Device Name
Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression) EUDAMED
Model / Reference
R1:20mL×1 R2:5mL×1（702） EUDAMED
R1:80mL×2 R2:20mL×2（706） EUDAMED
R1:48mL×2 R2:12mL×2（713） EUDAMED
R1:48mL×2 R2:12mL×2（705） EUDAMED
R1:100mL×1 R2:25mL×1（708） EUDAMED
Quality Control: 2mL×1（92104） EUDAMED
Quality Control: 2mL×1（92104） EUDAMED
R1:40mL×4 R2:20mL×2（704） EUDAMED
R1:20mL×4 R2:5mL×4（709） EUDAMED
R1:48mL×2 R2:12mL×2（716） EUDAMED
R1:64mL×6 R2:48mL×2（795） EUDAMED
R1:20mL×4 R2:5mL×4（710） EUDAMED
R1:48mL×2 R2:24mL×1（792） EUDAMED
R1:48mL×2 R2:24mL×1（791） EUDAMED
R1:50ml×2 R2:25ml×1（793） EUDAMED
R1:20mL×4 R2:5mL×4（796） EUDAMED
R1:64mL×2 R2:16mL×2（794） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674863663 EUDAMED
06971674863694 EUDAMED
06971674863717 EUDAMED
06971674863687 EUDAMED
06971674863700 EUDAMED
06971674868217 EUDAMED
06971674863670 EUDAMED
06971674863656 EUDAMED
06971674863731 EUDAMED
06936895305194 EUDAMED
06936895305149 EUDAMED
06936895305163 EUDAMED
06936895305156 EUDAMED
06936895305170 EUDAMED
06936895305132 EUDAMED
06936895305187 EUDAMED
Basic UDI-DI
B-06971674863663 EUDAMED
B-06971674863694 EUDAMED
B-06971674863717 EUDAMED
B-06971674863687 EUDAMED
B-06971674863700 EUDAMED
B-06971674868217 EUDAMED
B-06971674863670 EUDAMED
B-06971674863656 EUDAMED
B-06971674863731 EUDAMED
B-06936895305194 EUDAMED
B-06936895305149 EUDAMED
B-06936895305163 EUDAMED
B-06936895305156 EUDAMED
B-06936895305170 EUDAMED
B-06936895305132 EUDAMED
B-06936895305187 EUDAMED
EMDN Code
W01010115 CREATINE KINASE ISOENZYMES 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-MB (CK-MB) Test Kit (Immune Suppression) by Biobase Biodustry(Shandong) 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
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (16)

  • EUDAMED f56322fa-e858-4159-995a-60708581442a 61 fields · synced Oct 6, 2026
  • EUDAMED d6955987-5ddd-407e-8206-d7267661122f 61 fields · synced May 17, 2026
  • EUDAMED af2114e7-43e6-4e7c-8d83-420c933b1cf6 61 fields · synced May 17, 2026
  • EUDAMED 57378ff7-e2a6-4539-ad2d-88da69b04815 61 fields · synced May 17, 2026
  • EUDAMED c3b16116-d88d-4ab0-899a-87c7a9e50e06 61 fields · synced May 18, 2026
  • EUDAMED c4f3e782-8fa5-4eba-8dac-c20b1a245278 61 fields · synced May 18, 2026
  • EUDAMED 275f85ec-cccb-45d6-a9bd-b23d5c6d3cba 61 fields · synced May 19, 2026
  • EUDAMED a93b99d5-6883-4f37-87c2-4382344a67a2 61 fields · synced May 19, 2026
  • EUDAMED ca168d00-6069-469d-a3b6-aa5c27cbeaef 61 fields · synced May 19, 2026
  • EUDAMED 501e16f8-b4f4-4fa0-8b7f-1e504cf19e29 61 fields · synced Jul 9, 2026
  • EUDAMED 305ff99c-5847-447a-8aec-673bb3b4d255 61 fields · synced Jul 9, 2026
  • EUDAMED 5ef39f1b-87a8-4955-9795-22c0a25dc082 61 fields · synced Jul 10, 2026
  • EUDAMED 793f10f3-7167-4e95-b72f-427e0682e0fa 61 fields · synced Jul 10, 2026
  • EUDAMED 37bec825-094b-4db3-8f31-d2f3be12583c 61 fields · synced Jul 12, 2026
  • EUDAMED 6f57b0dc-4c95-4951-89c9-1c5a31f8d512 61 fields · synced Jul 19, 2026
  • EUDAMED 5e23ad1f-e7c1-40f2-9256-35ecab879088 61 fields · synced Jul 30, 2026