← Back to catalogue
Immunoglobulin A Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090306Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH090308Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH090307Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH090301Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH090309Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH090310Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH090311Model R1: 80 mL×4; R2: 80 mL×1
Identity
- Device Name
- Immunoglobulin A Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH090306 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH090308 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH090307 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH090301 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH090309 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH090310 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462930 EUDAMED06975225462954 EUDAMED06975225462947 EUDAMED06975225462985 EUDAMED06975225462961 EUDAMED06975225462978 EUDAMED06975225462992 EUDAMED
- Basic UDI-DI
- B-06975225462930 EUDAMEDB-06975225462954 EUDAMEDB-06975225462947 EUDAMEDB-06975225462985 EUDAMEDB-06975225462961 EUDAMEDB-06975225462978 EUDAMEDB-06975225462992 EUDAMED
- EMDN Code
- W0102010101 IMMUNOGLOBULIN 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
Immunoglobulin A Assay Kit (Immunoturbidimetric 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-06975225462930 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
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 4f8108fe-57d2-4e68-a7c6-ff6418e7c66a 61 fields · synced Aug 2, 2026
- EUDAMED 05d88385-16df-4fd6-b4bc-69a206917d14 61 fields · synced May 18, 2026
- EUDAMED de1cad38-8ecc-4225-af55-b38485ef0ef6 61 fields · synced May 18, 2026
- EUDAMED 351015e8-a4e7-4105-841d-7c627f8b5783 61 fields · synced May 18, 2026
- EUDAMED b7babf03-8ae2-442d-b6dd-df33f682307a 61 fields · synced May 18, 2026
- EUDAMED 94036df2-51bf-41c0-a55f-3a8c24534a7c 61 fields · synced May 19, 2026
- EUDAMED 5f011f10-766e-42c2-950a-f834bcdfb46b 61 fields · synced May 19, 2026