← Back to catalogue
FREND D-Dimer
EUDAMEDClass IVD General (EU MDR)
Ref FRDD 025Model FREND D-DimerModel FREND D-Dimer
Identity
- Trade Name
- FREND D-Dimer EUDAMED
- Device Name
- FRDD 025 EUDAMED
- Model / Reference
- FREND D-Dimer EUDAMEDFRDD 025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540641 EUDAMED
- Basic UDI-DI
- B-08809317540641 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
FREND D-Dimer by NanoEnTek, 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-08809317540641 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED ceabc641-1474-45e7-ab70-050038ad6249 61 fields · synced Jun 19, 2026
- EUDAMED fecff936-1074-46af-951c-90e0e39bb293 61 fields · synced Jun 19, 2026