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β2-Microglobulin Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030603CModel R1: 60 mL×1; R2: 15 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030604CModel R1: 40 mL×3; R2: 30 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030606CModel R1: 90 mL×2; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030601CModel R1: 60 mL×3; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030606Model R1: 90 mL×2; R2: 15 mL×3
Identity
- Device Name
- β2-Microglobulin Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 60 mL×1; R2: 15 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030603C EUDAMEDR1: 40 mL×3; R2: 30 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030604C EUDAMEDR1: 90 mL×2; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030606C EUDAMEDR1: 60 mL×3; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030601C EUDAMEDR1: 90 mL×2; R2: 15 mL×3 EUDAMEDDTSH030606 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463791 EUDAMED06975225463814 EUDAMED06975225463876 EUDAMED06975225463838 EUDAMED06975225463869 EUDAMED
- Basic UDI-DI
- B-06975225463791 EUDAMEDB-06975225463814 EUDAMEDB-06975225463876 EUDAMEDB-06975225463838 EUDAMEDB-06975225463869 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) 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
Category: Apolipoprotein B (Apo B) IVD, reagent
β2-Microglobulin Assay Kit (Latex Immunoturbidimetric Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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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-06975225463791 | 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 c17664ad-d265-4fc7-873a-48fe00c0dc7a 61 fields · synced Jul 18, 2026
- EUDAMED 286209eb-8d15-4762-b38d-320d3b6b027d 61 fields · synced May 17, 2026
- EUDAMED 8fea4a80-d270-4327-9e43-fd0b4f768719 61 fields · synced May 17, 2026
- EUDAMED e0fe6ab2-15e2-47de-a936-ff58a7ef1354 61 fields · synced May 18, 2026
- EUDAMED ac454437-fa80-4d4b-ad0f-3cf13ab2bcb7 61 fields · synced May 18, 2026