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PAPAYA 3D Premium Plus

by GENORAY CO., Ltd.

Ref 705

PAPAYA 3D Premium Plus (705) is a medical device (EU MDD Class IIb; FDA Class II; EMDN category equipment for extraoral dental radiology) made by Genoray Co., Ltd., registered in EUDAMED on 14 Aug 2024 (Basic UDI-DI B-08809244060281), cleared under FDA 510(k) K200469 on 16 Sep 2020 and listed in FDA GUDID since 24 Mar 2025 (UDI-DI 08809244060281), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200469↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809244060281 UDI-DI Date24 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08809244060281 Basic UDI-DI 08809244060281UDI-DIDate14 Aug 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK200469 Date16 Sep 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809244060281 registered 14 Aug 2024 Active
  • FDA 510(k) K200469 decided 16 Sep 2020 Active
  • FDA GUDID UDI-DI 08809244060281 listed 24 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200469
  2. Registered EUDAMED B-08809244060281
  3. Listed FDA GUDID 08809244060281

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
PAPAYA 3D Premium Plus EUDAMED
Genoray GUDID
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / reference
705 EUDAMED
PAPAYA 3D Premium Plus GUDID
Primary DI / UDI-DI
08809244060281
Basic UDI-DI
B-08809244060281
510(k) Number
FDA product code
OAS, MUH
EMDN code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750, 872.1800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
705
GUDID
PAPAYA 3D Premium Plus
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-000021014
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL.

Other devices from Genoray Co., Ltd.

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    Class II

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See all devices from Genoray Co., Ltd. →

Properties

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