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Direct Bilirubin (DBIL) Test Kit (DCA)

EUDAMED

Class IVD General (EU MDR)

Ref R1:50mL×2 R2:25mL×1（793）Ref R1:20mL×4 R2:5mL×4（707）Ref R1:64mL×6 R2:48mL×2（795）Ref R1:48mL×2 R2:12mL×2（716）Ref R1:48mL×2 R2:12mL×2（798）Ref R1:20mL×1 R2:5mL×1（702）Ref R1:100mL×1 R2:25mL×1（708）Ref R1:80mL×1 R2:20mL×1（703）Ref R1:20mL×4 R2:5mL×4（709）Ref R1:48mL×2 R2:12mL×2（713）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Direct Bilirubin (DBIL) Test Kit (DCA) EUDAMED
Device Name
Direct Bilirubin (DBIL) Test Kit (DCA) EUDAMED
Model / Reference
R1:50mL×2 R2:25mL×1（793） EUDAMED
R1:20mL×4 R2:5mL×4（707） EUDAMED
R1:64mL×6 R2:48mL×2（795） EUDAMED
R1:48mL×2 R2:12mL×2（716） EUDAMED
R1:48mL×2 R2:12mL×2（798） EUDAMED
R1:20mL×1 R2:5mL×1（702） EUDAMED
R1:100mL×1 R2:25mL×1（708） EUDAMED
R1:80mL×1 R2:20mL×1（703） EUDAMED
R1:20mL×4 R2:5mL×4（709） EUDAMED
R1:48mL×2 R2:12mL×2（713） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674862864 EUDAMED
06971674862826 EUDAMED
06971674862871 EUDAMED
06971674862925 EUDAMED
06971674862895 EUDAMED
06971674862772 EUDAMED
06971674862833 EUDAMED
06971674862789 EUDAMED
06971674862765 EUDAMED
06971674862901 EUDAMED
Basic UDI-DI
B-06971674862864 EUDAMED
B-06971674862826 EUDAMED
B-06971674862871 EUDAMED
B-06971674862925 EUDAMED
B-06971674862895 EUDAMED
B-06971674862772 EUDAMED
B-06971674862833 EUDAMED
B-06971674862789 EUDAMED
B-06971674862765 EUDAMED
B-06971674862901 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

Direct Bilirubin (DBIL) Test Kit (DCA) 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

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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 (10)

  • EUDAMED 31cea80b-4a38-4c63-9b4f-43ba00f5d02d 61 fields · synced Oct 6, 2026
  • EUDAMED e82b6b87-165e-4e1d-8502-34e19775e617 61 fields · synced May 11, 2026
  • EUDAMED 09f620a5-fe72-464f-aa87-ab5f5ffdd15f 61 fields · synced May 11, 2026
  • EUDAMED 5476cd72-6788-424a-9c38-2ba4bcbd91c4 61 fields · synced May 17, 2026
  • EUDAMED b8c58f52-1f5b-4b81-a35b-048c7a754154 61 fields · synced May 17, 2026
  • EUDAMED e0c4854f-453c-4c33-a0d4-521e3f250b14 61 fields · synced May 17, 2026
  • EUDAMED 609ddcd7-b3fb-4f76-8cab-9158267e77bf 61 fields · synced May 18, 2026
  • EUDAMED 53e7bc09-0e74-49c3-96f4-6b2067dc8723 61 fields · synced May 18, 2026
  • EUDAMED 54d38b55-7496-4b41-9228-5bdbdf8baa06 61 fields · synced May 19, 2026
  • EUDAMED 24535964-a520-4ec0-ae4c-c447da2737e6 61 fields · synced May 19, 2026