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Complement3 Reagent Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000981Model Calibration sample: 1×1mLRef 3004600Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mLRef 3021636Model R1: 1x50mL, R2: 1x10mL,Ref 3021163Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL, Ref 3021655Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL
Identity
- Trade Name
- COMPLEMENT3 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- COMPLEMENT3 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- Calibration sample: 1×1mL EUDAMED3000981 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL EUDAMED3004600 EUDAMEDR1: 1x50mL, R2: 1x10mL, EUDAMED3021636 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL, EUDAMED3021163 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1mL EUDAMED3021655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261657 EUDAMED06942202246784 EUDAMED06925794592255 EUDAMED06942202260070 EUDAMED06925794592248 EUDAMED
- Basic UDI-DI
- B-06942202261657 EUDAMEDB-06942202246784 EUDAMEDB-06925794592255 EUDAMEDB-06942202260070 EUDAMEDB-06925794592248 EUDAMED
- EMDN Code
- W0102010203 COMPLEMENT COMPONENT C3/C3C EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
No
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
Complement3 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-06942202261657 | 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 53300087-586f-494c-af15-0c1f9362849b 61 fields · synced Aug 1, 2026
- EUDAMED 74e8006c-21e0-4c02-8e3b-ec82539004a8 61 fields · synced May 17, 2026
- EUDAMED f3279f35-6716-437a-bcbd-249b2865bdc2 61 fields · synced Jul 9, 2026
- EUDAMED 774dbad0-5c29-4254-85e8-5f099a5c835e 61 fields · synced Jul 11, 2026
- EUDAMED fa1bdcf6-b85d-4248-a109-7fae208e635d 61 fields · synced Jul 21, 2026