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Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation)

EUDAMED

Class IVD General (EU MDR)

Ref R1:48mL×2 R2:12mL×2（716）Ref R1:100mL×1 R2:25mL×1（708）Ref R1:48mL×2 R2:24mL×1（791）Ref R1:48mL×2 R2:12mL×2（715）Ref R1:48mL×2 R2:12mL×2（705）Ref R1:48mL×2 R2:24mL×1（793）Ref R1:80mL×1 R2:20mL×1（703）Ref R1:64mL×6 R2:48mL×2（795）Ref R1:80mL×2 R2:20mL×2（706）Ref R1:20mL×4 R2:5mL×4（707）Ref R1:20mL×4 R2:5mL×4（710）Ref R1:48mL×2 R2:24mL×1（792）Ref R1:48mL×2 R2:12mL×2（713）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation) EUDAMED
Device Name
Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation) EUDAMED
Model / Reference
R1:48mL×2 R2:12mL×2（716） EUDAMED
R1:100mL×1 R2:25mL×1（708） EUDAMED
R1:48mL×2 R2:24mL×1（791） EUDAMED
R1:48mL×2 R2:12mL×2（715） EUDAMED
R1:48mL×2 R2:12mL×2（705） EUDAMED
R1:48mL×2 R2:24mL×1（793） EUDAMED
R1:80mL×1 R2:20mL×1（703） EUDAMED
R1:64mL×6 R2:48mL×2（795） EUDAMED
R1:80mL×2 R2:20mL×2（706） EUDAMED
R1:20mL×4 R2:5mL×4（707） EUDAMED
R1:20mL×4 R2:5mL×4（710） EUDAMED
R1:48mL×2 R2:24mL×1（792） EUDAMED
R1:48mL×2 R2:12mL×2（713） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674868927 EUDAMED
06971674868828 EUDAMED
06971674868835 EUDAMED
06971674868910 EUDAMED
06971674868798 EUDAMED
06971674868859 EUDAMED
06971674868774 EUDAMED
06971674868866 EUDAMED
06971674868804 EUDAMED
06971674868811 EUDAMED
06971674868897 EUDAMED
06971674868842 EUDAMED
06971674868903 EUDAMED
Basic UDI-DI
B-06971674868927 EUDAMED
B-06971674868828 EUDAMED
B-06971674868835 EUDAMED
B-06971674868910 EUDAMED
B-06971674868798 EUDAMED
B-06971674868859 EUDAMED
B-06971674868774 EUDAMED
B-06971674868866 EUDAMED
B-06971674868804 EUDAMED
B-06971674868811 EUDAMED
B-06971674868897 EUDAMED
B-06971674868842 EUDAMED
B-06971674868903 EUDAMED
EMDN Code
W01010203 BILIRUBIN 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

Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation) 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 (13)

  • EUDAMED 098414fe-a6b3-45f2-8fc2-512f95421846 61 fields · synced Oct 6, 2026
  • EUDAMED 0a013fda-7fa7-4e4a-8118-808d728e0787 61 fields · synced May 16, 2026
  • EUDAMED 1b78d4cc-10b3-4230-8882-3f513065c604 61 fields · synced May 16, 2026
  • EUDAMED 9879edb6-f726-455f-87ef-1cb55c5714a8 61 fields · synced May 17, 2026
  • EUDAMED 79dc2d85-9be5-447e-b44b-c25467848ccc 61 fields · synced May 18, 2026
  • EUDAMED fae2bb3f-d14e-4c5e-bfcf-db0847620d08 61 fields · synced May 18, 2026
  • EUDAMED d0242220-8fd6-496e-8bfd-5da0ecb1ca5d 61 fields · synced May 18, 2026
  • EUDAMED 11978218-d38a-4380-8d8f-22389ee14a62 61 fields · synced May 18, 2026
  • EUDAMED 8493879e-7774-4785-b49d-754eb7871ba7 61 fields · synced May 18, 2026
  • EUDAMED 92e72e0e-cf3a-48d3-bb89-18d57a6510d2 61 fields · synced May 19, 2026
  • EUDAMED 387b6961-ba1b-4afa-a7c9-14eba7a0fdea 61 fields · synced May 19, 2026
  • EUDAMED 3c7b725e-a5a2-4883-860a-263e18a77d86 61 fields · synced May 19, 2026
  • EUDAMED 9e7aae8b-c624-4511-8c0c-c3e9f0764a98 61 fields · synced May 19, 2026