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F200

by Fussen Technology Co., Ltd.

Ref F200

F200 is a digital imaging phosphor plate (EU MDD Class IIa; FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital) made by Fussen Technology Co., Ltd., registered in EUDAMED on 30 Jun 2023 (Basic UDI-DI B-06974566272055), cleared under FDA 510(k) K192766 on 5 Dec 2019 and listed in FDA GUDID since 21 Nov 2025 (UDI-DI 06974566272055), active as of 22 Oct 2026.

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

CE MDD 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) K192766

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974566272055 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06974566272055 Basic UDI-DI 06974566272055UDI-DIDate30 Jun 2023RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK192766 Date5 Dec 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06974566272055 registered 30 Jun 2023 Active
  • FDA 510(k) K192766 decided 5 Dec 2019 Active
  • FDA GUDID UDI-DI 06974566272055 listed 21 Nov 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192766
  2. Registered EUDAMED B-06974566272055
  3. Listed FDA GUDID 06974566272055

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Fussen
Generic name
Digital imaging phosphor plate, dental, intraoral
Model / reference
F200
Primary DI / UDI-DI
06974566272055 EUDAMED
06974566272000 GUDID
Basic UDI-DI
B-06974566272055
510(k) Number
FDA product code
MUH
EMDN code
Z1103040102 Equipment for digital endoral radiology
GMDN term
Digital imaging phosphor plate, dental, intraoral
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06974566272055
GUDID
06974566272000
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06974566272055; FDA GUDID lists 06974566272000), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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
CN-MF-000009373
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Dental digital imaging sensor, intraoral

Similar devices in this category

Other devices filed under EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY.

Other devices from Fussen Technology Co., Ltd.

See all devices from Fussen Technology Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)