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Total Bilirubin (TBIL) Test Kit (DCA)
EUDAMEDClass IVD General (EU MDR)
Ref R1:100mL×1 R2:25mL×1（708）Ref R1:48mL×2 R2:24mL×1（791）Ref R1:48mL×2 R2:12mL×2（716）Ref R1:20mL×4 R2:5mL×4（796）Ref R1:48mL×2 R2:12mL×2（705）Ref R1:48mL×2 R2:24mL×1（792）Ref R1:20mL×4 R2:5mL×4（707）
Identity
- Trade Name
- Total Bilirubin (TBIL) Test Kit (DCA) EUDAMED
- Device Name
- Total Bilirubin (TBIL) Test Kit (DCA) EUDAMED
- Model / Reference
- R1:100mL×1 R2:25mL×1（708） EUDAMEDR1:48mL×2 R2:24mL×1（791） EUDAMEDR1:48mL×2 R2:12mL×2（716） EUDAMEDR1:20mL×4 R2:5mL×4（796） EUDAMEDR1:48mL×2 R2:12mL×2（705） EUDAMEDR1:48mL×2 R2:24mL×1（792） EUDAMEDR1:20mL×4 R2:5mL×4（707） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674862659 EUDAMED06971674862666 EUDAMED06971674862741 EUDAMED06971674862703 EUDAMED06971674862628 EUDAMED06971674862673 EUDAMED06971674862642 EUDAMED
- Basic UDI-DI
- B-06971674862659 EUDAMEDB-06971674862666 EUDAMEDB-06971674862741 EUDAMEDB-06971674862703 EUDAMEDB-06971674862628 EUDAMEDB-06971674862673 EUDAMEDB-06971674862642 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 (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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971674862659 | Class IVD General | Active |
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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 (7)
- EUDAMED 266ad12f-4052-4b8f-bd88-a3492d57906b 61 fields · synced Oct 6, 2026
- EUDAMED f14c3d54-2826-435c-95c1-28d261f0c521 61 fields · synced May 17, 2026
- EUDAMED 037cfa29-0db7-4730-934b-849a14de74ef 61 fields · synced May 17, 2026
- EUDAMED 0d30df4f-a0b0-4d24-b322-f7d430877eb2 61 fields · synced May 17, 2026
- EUDAMED 1f618c02-6cf9-498f-9e47-67e3f728a77d 61 fields · synced May 17, 2026
- EUDAMED c7fb8b6e-2305-4160-87cc-7c4594149b08 61 fields · synced May 17, 2026
- EUDAMED c4e26a7d-2e53-4d77-ac69-aecec532872b 61 fields · synced May 19, 2026