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Alanine Aminotransferase Assay Kit (Lactate Dehydrogenase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020209Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH020206Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH020202Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH020203Model R1: 80 mL×4; R2: 80 mL×1
Identity
- Device Name
- Alanine Aminotransferase Assay Kit (Lactate Dehydrogenase Method) EUDAMED
- Model / Reference
- R1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH020209 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH020206 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH020202 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH020203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460615 EUDAMED06975225460585 EUDAMED06975225460639 EUDAMED06975225460646 EUDAMED
- Basic UDI-DI
- B-06975225460615 EUDAMEDB-06975225460585 EUDAMEDB-06975225460639 EUDAMEDB-06975225460646 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE 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
Alanine Aminotransferase Assay Kit (Lactate Dehydrogenase 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-06975225460615 | 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 d19332be-070c-48b1-80c6-b9fd9c1689f7 61 fields · synced Jul 27, 2026
- EUDAMED 5694faac-8b3c-4cfd-af3f-8244d5eb53b1 61 fields · synced May 17, 2026
- EUDAMED fa41d0f3-92d8-4a78-a45a-1976f3d1fa14 61 fields · synced May 17, 2026
- EUDAMED 6df7d908-9084-4437-9900-2fce3a8be295 61 fields · synced May 19, 2026