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Complement4 Reagent Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3012509Model R1: 1x50mL, R2: 1x10mLRef 3000991Model Calibration sample: 1×1mLRef 3021656Model R1: 1x50mL, R2: 1x10mL,Ref 3023555Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1mLRef 3023560Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL,
Identity
- Trade Name
- COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL EUDAMED3012509 EUDAMEDCalibration sample: 1×1mL EUDAMED3000991 EUDAMEDR1: 1x50mL, R2: 1x10mL, EUDAMED3021656 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL EUDAMED3023555 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL, EUDAMED3023560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260100 EUDAMED06942202261664 EUDAMED06925794592279 EUDAMED06942202215728 EUDAMED06942202215711 EUDAMED
- Basic UDI-DI
- B-06942202260100 EUDAMEDB-06942202261664 EUDAMEDB-06925794592279 EUDAMEDB-06942202215728 EUDAMEDB-06942202215711 EUDAMED
- EMDN Code
- W0102010205 COMPLEMENT COMPONENT C4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
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
Complement4 Reagent Kit（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202260100 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 149c98f3-4ea6-48e7-b1c5-191df90d3a11 61 fields · synced Sep 17, 2026
- EUDAMED 4e1a6b0f-4ff9-4bfb-b197-29470732f4cb 61 fields · synced May 19, 2026
- EUDAMED 38cd9872-e099-41ca-adc6-6d92baf818ae 61 fields · synced Jul 9, 2026
- EUDAMED 0acffa0b-afe1-4432-adf3-836b4548f3b0 61 fields · synced Jul 13, 2026
- EUDAMED 423482e1-c08e-404e-8b66-c5256975ad98 61 fields · synced Sep 17, 2026