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α1-Microglobulin Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH030701CModel R1: 60 mL×3; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030705Model R1: 80 mL×3; R2: 20 mL×3Ref DTSH030702Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH030703CModel R1: 60 mL×1; R2: 15 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1Model R1: 20 mL×1; R2: 5 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030706CModel R1: 90 mL×2; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH030703Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH030704Model R1: 40 mL×3; R2: 30 mL×1
Identity
- Device Name
- α1-Microglobulin Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 60 mL×3; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030701C EUDAMEDR1: 80 mL×3; R2: 20 mL×3 EUDAMEDDTSH030705 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH030702 EUDAMEDR1: 60 mL×1; R2: 15 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030703C EUDAMEDR1: 20 mL×1; R2: 5 mL×1; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDR1: 90 mL×2; R2: 15 mL×3; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH030706C EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH030703 EUDAMEDR1: 40 mL×3; R2: 30 mL×1 EUDAMEDDTSH030704 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463715 EUDAMED06975225463722 EUDAMED06975225463647 EUDAMED06975225463678 EUDAMED06975225463654 EUDAMED06975225463753 EUDAMED06975225463661 EUDAMED06975225463685 EUDAMED
- Basic UDI-DI
- B-06975225463715 EUDAMEDB-06975225463722 EUDAMEDB-06975225463647 EUDAMEDB-06975225463678 EUDAMEDB-06975225463654 EUDAMEDB-06975225463753 EUDAMEDB-06975225463661 EUDAMEDB-06975225463685 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
α1-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-06975225463715 | 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 (8)
- EUDAMED 3a1b4e1c-f0a3-426f-9d1e-d04673e6ca03 61 fields · synced Aug 2, 2026
- EUDAMED b4e31126-40e3-43ba-9d65-7f2c874ab8ab 61 fields · synced May 16, 2026
- EUDAMED 569570e7-924f-4202-b3bb-a00905894f3d 61 fields · synced May 16, 2026
- EUDAMED a6cf31c7-0859-4cbd-b9ba-2bf73377c6d1 61 fields · synced May 17, 2026
- EUDAMED f4e80a91-ab30-4c1b-814a-5bfa623d7700 61 fields · synced May 17, 2026
- EUDAMED b9bdb0e4-4f1a-4474-815b-19689d26ebd9 61 fields · synced May 17, 2026
- EUDAMED 1081c24e-6cef-4794-9af6-37c879a9c025 61 fields · synced May 17, 2026
- EUDAMED 02eef95b-420f-419a-b215-a5389dec3c88 61 fields · synced May 18, 2026