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Total Bile Acid Assay Kit (Enzyme Cycling Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020105Model R1: 21 mL×1; R2: 7 mL×1Ref DTSH020108Model R1: 30 mL×3; R2: 30 mL×1Ref DTSH020109Model R1: 60 mL×2; R2: 20 mL×2Ref DTSH020106Model R1: 30 mL×1; R2: 10 mL×1
Identity
- Device Name
- Total Bile Acid Assay Kit (Enzyme Cycling Method) EUDAMED
- Model / Reference
- R1: 21 mL×1; R2: 7 mL×1 EUDAMEDDTSH020105 EUDAMEDR1: 30 mL×3; R2: 30 mL×1 EUDAMEDDTSH020108 EUDAMEDR1: 60 mL×2; R2: 20 mL×2 EUDAMEDDTSH020109 EUDAMEDR1: 30 mL×1; R2: 10 mL×1 EUDAMEDDTSH020106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462688 EUDAMED06975225462718 EUDAMED06975225462725 EUDAMED06975225462695 EUDAMED
- Basic UDI-DI
- B-06975225462688 EUDAMEDB-06975225462718 EUDAMEDB-06975225462725 EUDAMEDB-06975225462695 EUDAMED
- EMDN Code
- W01010202 BILE ACIDS 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
Yes
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 Bile Acid Assay Kit (Enzyme Cycling 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-06975225462688 | 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 (4)
- EUDAMED 30dca5e3-2a91-465b-bc5f-4dbd1c3337b2 61 fields · synced Jul 20, 2026
- EUDAMED da46d260-9972-4523-9247-a335f98bd4f8 61 fields · synced May 17, 2026
- EUDAMED a7a28c3b-37b7-4c4b-ac5b-8c53646bd79f 61 fields · synced May 18, 2026
- EUDAMED 86d45a7a-584c-4543-9aad-934a4ab8375d 61 fields · synced May 18, 2026