Identity
- Device Name
- D-Dimer Rapid Test Kit (FIA) EUDAMED
- Model / Reference
- 25Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970664751959 EUDAMED
- Basic UDI-DI
- B-06970664751959 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
D-Dimer Rapid Test Kit (FIA) by Beijing Kewei Clinical Diagnostic Reagent Inc — 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-06970664751959 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Kewei Clinical Diagnostic Reagent Inc
- EUDAMED SRN
- CN-MF-000019125
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5c34010a-0266-4f68-8cc5-ef75abb0c8ea 61 fields · synced Jul 12, 2026