← Back to catalogue
Dirui
EUDAMEDClass IVD General (EU MDR)
Ref R1:4×40mL R1:2×20mL Calibrator:1×1mL Control :2×1mL
Identity
- Trade Name
- DIRUI EUDAMED
- Device Name
- Complement C1q Reagent Kit (Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- R1:4×40mL R1:2×20mL Calibrator:1×1mL Control :2×1mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202228124 EUDAMED
- Basic UDI-DI
- B-06942202228124 EUDAMED
- EMDN Code
- W0102010201 COMPLEMENT COMPONENT C1Q EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
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
Dirui 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-06942202228124 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 736d8019-70ef-4164-96d4-ccdc9e037075 61 fields · synced May 23, 2026