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5’-Nucleotidase Assay Kit (Peroxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH021006CModel R1: 70 mL×4; R2: 70 mL×2; Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH021002Model R1: 20 mL×1; R2: 10 mL×1Ref DTSH021004Model R1: 40 mL×2; R2: 20 mL×2Ref DTSH021006Model R1: 70 mL×4; R2: 70 mL×2Ref DTSH021001Model R1: 40 mL×4; R2: 20 mL×4Ref DTSH021001CModel R1: 40 mL×4; R2: 20 mL×4; Calibrator: 1 mL × 1; quality control: 1 mL × 1
Identity
- Device Name
- 5’-Nucleotidase Assay Kit (Peroxidase Method) EUDAMED
- Model / Reference
- R1: 70 mL×4; R2: 70 mL×2; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH021006C EUDAMEDR1: 20 mL×1; R2: 10 mL×1 EUDAMEDDTSH021002 EUDAMEDR1: 40 mL×2; R2: 20 mL×2 EUDAMEDDTSH021004 EUDAMEDR1: 70 mL×4; R2: 70 mL×2 EUDAMEDDTSH021006 EUDAMEDR1: 40 mL×4; R2: 20 mL×4 EUDAMEDDTSH021001 EUDAMEDR1: 40 mL×4; R2: 20 mL×4; Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH021001C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225464118 EUDAMED06975225464002 EUDAMED06975225464040 EUDAMED06975225464101 EUDAMED06975225464064 EUDAMED06975225464071 EUDAMED
- Basic UDI-DI
- B-06975225464118 EUDAMEDB-06975225464002 EUDAMEDB-06975225464040 EUDAMEDB-06975225464101 EUDAMEDB-06975225464064 EUDAMEDB-06975225464071 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
5’-Nucleotidase Assay Kit (Peroxidase 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-06975225464118 | 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 (6)
- EUDAMED 077537fb-831c-45d5-966a-c9992f8d59e0 61 fields · synced Aug 2, 2026
- EUDAMED 21025fba-3b02-4372-aa1f-092b39cfd97d 61 fields · synced May 11, 2026
- EUDAMED 6fb28691-3d88-4d14-bd05-dbd4f44f49f8 61 fields · synced May 18, 2026
- EUDAMED 76cf24ff-e43e-4f74-be18-643ac7f15378 61 fields · synced May 18, 2026
- EUDAMED 170ab910-8fa1-4782-b924-f2f573687428 61 fields · synced May 18, 2026
- EUDAMED d5e67485-06ec-4fc6-9df5-74f1aa06adc3 61 fields · synced May 18, 2026