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Immunoglobulin G Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090411Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH090405Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH090407Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH090409Model R1: 60 mL×2; R2: 15 mL×2
Identity
- Device Name
- Immunoglobulin G Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090411 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH090405 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH090407 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH090409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462381 EUDAMED06975225462312 EUDAMED06975225462336 EUDAMED06975225462350 EUDAMED
- Basic UDI-DI
- B-06975225462381 EUDAMEDB-06975225462312 EUDAMEDB-06975225462336 EUDAMEDB-06975225462350 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G 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 G 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-06975225462381 | 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 (4)
- EUDAMED 494143a5-a5e6-4155-8ca8-03e401d061a4 61 fields · synced Aug 1, 2026
- EUDAMED d7b143c1-d98d-4b45-872a-53b8dc6fe313 61 fields · synced May 17, 2026
- EUDAMED 2fbfaf80-aa9d-4870-b95d-331cea41b902 61 fields · synced May 18, 2026
- EUDAMED 0a9822cc-182d-45ec-8674-b111044ff9b2 61 fields · synced May 19, 2026