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Adenosine Deaminase Assay Kit (Peroxidase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020902Model R1: 20 mL×1; R2: 10 mL×1Ref DTSH020905Model R1: 60 mL×2; R2: 60 mL×1Ref DTSH020901CModel R1: 40 mL×4; R2: 20 mL×4; Calibrator: 2 mL × 1; quality control: 2 mL × 1Ref DTSH020906Model R1: 70 mL×4; R2: 70 mL×2Ref DTSH020901Model R1: 40 mL×4; R2: 20 mL×4Ref DTSH020905CModel R1: 60 mL×2; R2: 60 mL×1; Calibrator: 2 mL × 1; quality control: 2 mL × 1Ref DTSH020906CModel R1: 70 mL×4; R2: 70 mL×2; Calibrator: 2 mL × 1; quality control: 2 mL × 1
Identity
- Device Name
- Adenosine Deaminase Assay Kit (Peroxidase Method) EUDAMED
- Model / Reference
- R1: 20 mL×1; R2: 10 mL×1 EUDAMEDDTSH020902 EUDAMEDR1: 60 mL×2; R2: 60 mL×1 EUDAMEDDTSH020905 EUDAMEDR1: 40 mL×4; R2: 20 mL×4; Calibrator: 2 mL × 1; quality control: 2 mL × 1 EUDAMEDDTSH020901C EUDAMEDR1: 70 mL×4; R2: 70 mL×2 EUDAMEDDTSH020906 EUDAMEDR1: 40 mL×4; R2: 20 mL×4 EUDAMEDDTSH020901 EUDAMEDR1: 60 mL×2; R2: 60 mL×1; Calibrator: 2 mL × 1; quality control: 2 mL × 1 EUDAMEDDTSH020905C EUDAMEDR1: 70 mL×4; R2: 70 mL×2; Calibrator: 2 mL × 1; quality control: 2 mL × 1 EUDAMEDDTSH020906C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463883 EUDAMED06975225463968 EUDAMED06975225463951 EUDAMED06975225463982 EUDAMED06975225463944 EUDAMED06975225463975 EUDAMED06975225463999 EUDAMED
- Basic UDI-DI
- B-06975225463883 EUDAMEDB-06975225463968 EUDAMEDB-06975225463951 EUDAMEDB-06975225463982 EUDAMEDB-06975225463944 EUDAMEDB-06975225463975 EUDAMEDB-06975225463999 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
Adenosine Deaminase 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-06975225463883 | 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 (7)
- EUDAMED cc7e6a3f-9704-4652-b2fc-e6cd24ce42f2 61 fields · synced Sep 18, 2026
- EUDAMED b0b6c014-7f96-4c32-b687-2e191b1441fa 61 fields · synced May 16, 2026
- EUDAMED ed47663c-bb1f-4aa2-8c94-cfd5c1fff29b 61 fields · synced May 17, 2026
- EUDAMED 1203030b-5177-4779-8e56-eb319bef0b0d 61 fields · synced May 17, 2026
- EUDAMED bfffb169-dee4-4f70-953c-a7a8b5d78ec3 61 fields · synced May 17, 2026
- EUDAMED 3d2f6f99-8f3e-4187-be51-f546f382f431 61 fields · synced May 19, 2026
- EUDAMED 13b42f06-ce4d-440a-8b96-857f1b0e1d12 61 fields · synced May 19, 2026