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Total Bilirubin Assay Kit (Chemical Oxidation Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020710Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH020706Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH020703Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH020709Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH020705Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Total Bilirubin Assay Kit (Chemical Oxidation Method) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH020710 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH020706 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH020703 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH020709 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH020705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462664 EUDAMED06975225462619 EUDAMED06975225462671 EUDAMED06975225462640 EUDAMED06975225462602 EUDAMED
- Basic UDI-DI
- B-06975225462664 EUDAMEDB-06975225462619 EUDAMEDB-06975225462671 EUDAMEDB-06975225462640 EUDAMEDB-06975225462602 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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 Assay Kit (Chemical Oxidation Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06975225462664 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 235d7d7b-3564-4c68-a1d9-eca6e795a111 61 fields · synced Aug 3, 2026
- EUDAMED a0ccf779-4fc8-4fd8-992b-d723c0efc126 61 fields · synced May 18, 2026
- EUDAMED c3b85590-607a-4704-af1c-7fadf58df556 61 fields · synced May 18, 2026
- EUDAMED f2d2969c-adad-40b5-872b-15271d58a07a 61 fields · synced May 19, 2026
- EUDAMED b6e51bd5-1d33-4d76-a982-942799c55c1f 61 fields · synced May 19, 2026