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FREND Thyroid Duo
EUDAMEDClass IVD General (EU MDR)
Ref FRTDAP 020Model FREND Thyroid DuoModel FREND Thyroid Duo
Identity
- Trade Name
- FREND Thyroid Duo EUDAMED
- Device Name
- FRTDAP 020 EUDAMED
- Model / Reference
- FREND Thyroid Duo EUDAMEDFRTDAP 020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540474 EUDAMED
- Basic UDI-DI
- B-08809317540474 EUDAMED
- EMDN Code
- W01020402,W01020410 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 Thyroid Duo 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-08809317540474 | 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 f68d9826-a898-4b4b-b58e-f180924b9ff8 61 fields · synced Jun 19, 2026
- EUDAMED 4dca05c5-3dfa-4da8-a9e4-7cfbdd7144a9 61 fields · synced Jun 19, 2026