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FREND Free T4

by NanoEntek, Inc. 2 variants

Ref FRT4 020Model FREND Free T4

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-08809317540191 Basic UDI-DI 08809317540191UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809317540191 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Free thyroxine (FT4) IVD, reagent
Device Name
FRT4 020
Model / Ref / Catalog
FREND Free T4, FRT4 020, FRT4-HB
Primary DI / UDI-DI
08809317540191
Basic UDI-DI
B-08809317540191
510(k) Number
FDA Product Code
CEC
EMDN Code
W01020402 Free thyroxine
GMDN Term
Free thyroxine (FT4) IVD, reagent
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1695
EU market of registration
Cyprus
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FREND Free T4
FRT4 020
GUDID
FRT4-HB
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000021903
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from NanoEnTek, Inc.

See all devices from NanoEnTek, Inc. →

Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No