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GF85-3P

by Samsung Electronics Co., Ltd

Ref GF85-3PModel GF85-3P/GF85-SP

GF85-3P is a stationary basic diagnostic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code KPR, System, X-Ray, Stationary) made by Samsung Electronics Co., Ltd, registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 8806090DGRGF001W2), cleared under FDA 510(k) K242478 on 19 Sep 2024 and listed in FDA GUDID since 18 Oct 2024 (UDI-DI 08806095799636), active as of 22 Oct 2026.

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

CE MDR 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) K242478

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/MDR EUDAMED Number8806090DGRGF001W2 Basic UDI-DI 08806095799636UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806095799636 UDI-DI Date18 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242478 Date19 Sep 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8806090DGRGF001W2 registered 21 Apr 2026 Active
  • FDA 510(k) K242478 decided 19 Sep 2024 Active
  • FDA GUDID UDI-DI 08806095799636 listed 18 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242478
  2. Listed FDA GUDID 08806095799636
  3. Registered EUDAMED 8806090DGRGF001W2

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Stationary basic diagnostic x-ray system, digital
Device name
Digital Diagnostic X-ray System
Model / reference
GF85-3P/GF85-SP, GF85-3P
Primary DI / UDI-DI
08806095799636
Basic UDI-DI
8806090DGRGF001W2
510(k) Number
FDA product code
KPR
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
System or procedure pack
System which is a device in itself
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 IIb
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
KR-MF-000020682
Authorised representative
Samsung Electronics GmbH DE-AR-000007005

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from Samsung Electronics Co., Ltd

See all devices from Samsung Electronics Co., Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)