← Back to catalogue
Total Bile Acid Assay Kit (Enzyme Cycling Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020107Model R1: 45 mL×1; R2: 15 mL×1
Identity
- Device Name
- Total Bile Acid Assay Kit (Enzyme Cycling Method) EUDAMED
- Model / Reference
- R1: 45 mL×1; R2: 15 mL×1 EUDAMEDDTSH020107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462701 EUDAMED
- Basic UDI-DI
- B-06975225462701 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-06975225462701 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 89988ac5-8bee-4794-9085-a6f9c4714d5d 61 fields · synced Jun 19, 2026