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Complement Component 4 Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090708Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH090705Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH090709Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH090605Model R1: 20mL×1; R2: 5mL×1Ref DTSH090711Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH090710Model R1: 60 mL×4; R2: 15 mL×4Ref DTSH090707Model R1: 60 mL×1; R2: 15 mL×1
Identity
- Device Name
- Complement Component 4 Assay Kit (Immunoturbidimetric Method) EUDAMEDComplement Component 3 Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH090708 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH090705 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH090709 EUDAMEDR1: 20mL×1; R2: 5mL×1 EUDAMEDDTSH090605 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090711 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH090710 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH090707 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463111 EUDAMED06975225463081 EUDAMED06975225463128 EUDAMED06975225463005 EUDAMED06975225463159 EUDAMED06975225463135 EUDAMED06975225463104 EUDAMED
- Basic UDI-DI
- B-06975225463111 EUDAMEDB-06975225463081 EUDAMEDB-06975225463128 EUDAMEDB-06975225463005 EUDAMEDB-06975225463159 EUDAMEDB-06975225463135 EUDAMEDB-06975225463104 EUDAMED
- EMDN Code
- W0102010205 COMPLEMENT COMPONENT C4 EUDAMEDW0102010203 COMPLEMENT COMPONENT C3/C3C 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
Complement Component 4 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-06975225463111 | 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 db198fc5-a8f2-4a15-af47-dcb1153f8412 61 fields · synced Jul 20, 2026
- EUDAMED ed7bac93-6646-4551-b7e8-aaf25805f278 61 fields · synced May 16, 2026
- EUDAMED 7b83326c-2324-4710-ada6-bdcc2bbe3ada 61 fields · synced May 17, 2026
- EUDAMED 8cbf1df2-6e20-4c95-bac5-b3d62868649b 61 fields · synced May 18, 2026
- EUDAMED a59ff848-13b6-4a9d-be90-70ffb69ba620 61 fields · synced May 18, 2026
- EUDAMED 8ae003c9-a1d4-4e4f-96a7-104fa7356fee 61 fields · synced May 19, 2026
- EUDAMED c8eea107-34c0-4a12-b8a6-da511c0eec83 61 fields · synced May 19, 2026