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D-Dimer test kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52026017Model 25T/kitRef 52027017Model 50T/Kit
Identity
- Trade Name
- D-Dimer test kit (Immunofluorescence) EUDAMED
- Device Name
- D-Dimer test kit (Immunofluorescence) EUDAMED
- Model / Reference
- 25T/kit EUDAMED52026017 EUDAMED50T/Kit EUDAMED52027017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334804536 EUDAMEDD-FA0013YZ EUDAMED
- Basic UDI-DI
- B-06950334804536 EUDAMEDB-FA0013YZ EUDAMED
- EMDN Code
- W0103020803 D-DIMER - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
D-Dimer test kit (Immunofluorescence) by Genrui Biotech 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-06950334804536 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED eb786566-93ca-4ccb-abe4-5f40fbe38d8e 61 fields · synced Jul 18, 2026
- EUDAMED 4a82073e-56df-46e4-890c-07d8d0a17415 61 fields · synced May 19, 2026