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FREND Cardiac Triple
EUDAMEDClass IVD General (EU MDR)
Ref FRCT 025Model FREND Cardiac TripleModel FREND Cardiac Triple
Identity
- Trade Name
- FREND Cardiac Triple EUDAMED
- Device Name
- FRCT 025 EUDAMED
- Model / Reference
- FREND Cardiac Triple EUDAMEDFRCT 025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540078 EUDAMED
- Basic UDI-DI
- B-08809317540078 EUDAMED
- EMDN Code
- W01021304,W01021306,W01021311 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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 Cardiac Triple 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-08809317540078 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED c700974a-1d38-4611-8214-2b36dd3a807a 61 fields · synced Jul 12, 2026
- EUDAMED 50db1109-ad49-4cb2-b32a-e2b20043bc76 61 fields · synced Jul 12, 2026