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Direct Bilirubin Assay Kit (Chemical Oxidation Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020810Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH020808Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH020807Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH020801Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH020809Model R1: 60 mL×2; R2: 15 mL×2
Identity
- Device Name
- Direct Bilirubin Assay Kit (Chemical Oxidation Method) EUDAMED
- Model / Reference
- R1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH020810 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH020808 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH020807 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH020801 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH020809 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462053 EUDAMED06975225462022 EUDAMED06975225462015 EUDAMED06975225462046 EUDAMED06975225462039 EUDAMED
- Basic UDI-DI
- B-06975225462053 EUDAMEDB-06975225462022 EUDAMEDB-06975225462015 EUDAMEDB-06975225462046 EUDAMEDB-06975225462039 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
EUDAMEDEUDAMED
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 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-06975225462053 | 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 01400b90-565b-47ac-b5d6-55ec20737783 61 fields · synced Jul 25, 2026
- EUDAMED 6c7fb75c-0bf3-4664-9331-df1b34993247 61 fields · synced May 16, 2026
- EUDAMED 4cbc80f6-03c7-41dd-ada8-f4dbba81a620 61 fields · synced May 17, 2026
- EUDAMED 6cfce072-139d-45b6-9885-266a7a4ac0c1 61 fields · synced May 18, 2026
- EUDAMED dd29c7f2-a055-45ef-8801-099e9edaaac0 61 fields · synced May 18, 2026