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Gempacs

by DRGEM Corporation

Ref GEMPACS

Gempacs is a radiological PACS-dedicated management software (EU MDR Class I; FDA Class I; FDA product code LMD, System, Digital Image Communications, Radiological) made by DRGEM Corporation, registered in EUDAMED on 4 May 2026 (Basic UDI-DI 88000111RPSGEM6000P2) and listed in FDA GUDID since 9 Sep 2024 (UDI-DI 08800011170028), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000111RPSGEM6000P2 Basic UDI-DI 08800011170028UDI-DIDate4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011170028 UDI-DI Date9 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000111RPSGEM6000P2 registered 4 May 2026 Active
  • FDA GUDID UDI-DI 08800011170028 listed 9 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800011170028
  2. Registered EUDAMED 88000111RPSGEM6000P2

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Gempacs EUDAMED
Drgem GUDID
Generic name
Radiological PACS-dedicated management software
Device name
Radiological PACS Software
Model / reference
GEMPACS
Primary DI / UDI-DI
08800011170028
Basic UDI-DI
88000111RPSGEM6000P2
FDA product code
LMD
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class I
Regulation number
892.2020
Special device type
Software
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000017990
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)