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FREND System

by NanoEntek, Inc.

Ref F10Model FREND System

FREND System (F10) is a device classified as Class A in the EU and Class I in the US made by NanoEnTek, Inc., registered in EUDAMED on 28 Feb 2024 (Basic UDI-DI 880931754FRENDKQ), cleared under FDA 510(k) K124056 on 29 May 2013 and listed in FDA GUDID since 4 May 2018 (UDI-DI 08809317540207), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K124056

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number880931754FRENDKQ Basic UDI-DI 08809317540207UDI-DIDate28 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08809317540207 UDI-DI Date4 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK124056 Date29 May 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880931754FRENDKQ registered 28 Feb 2024 Active
  • FDA 510(k) K124056 decided 29 May 2013 Active
  • FDA GUDID UDI-DI 08809317540207 listed 4 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K124056
  2. Listed FDA GUDID 08809317540207
  3. Registered EUDAMED 880931754FRENDKQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Fluorescent immunoassay analyser IVD, point-of-care
Model / reference
FREND System, F10
Primary DI / UDI-DI
08809317540207
Basic UDI-DI
880931754FRENDKQ
510(k) Number
FDA product code
KHO
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Fluorescent immunoassay analyser IVD, point-of-care
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2560
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from NanoEnTek, Inc.

See all devices from NanoEnTek, Inc. →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)