Drgem Diamond-5A

Ref DIAMOND-5AModel DIAMOND-5A, DIAMOND-6A, DIAMOND-8A

Drgem Diamond-5A is a device classified as Class IIb in the EU and Class II in the US made by DRGEM Corporation, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 88000111DSDIA4000GM), cleared under FDA 510(k) K202156 on 10 Sep 2020 (1 earlier submission) and listed in FDA GUDID since 29 May 2017 (UDI-DI 08800011140151), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202156

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number88000111DSDIA4000GM Basic UDI-DI	Date21 May 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK202156	Date10 Sep 2020Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK192453	Date1 Oct 2019Decided	StatusActive
United States	GUDID listing GUDID	Number08800011140151 UDI-DI	Date29 May 2017Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 88000111DSDIA4000GM — open Devices and search for it
AccessGUDID record UDI-DI 08800011140151
AccessGUDID record UDI-DI 08800011140007
AccessGUDID record UDI-DI 08800011140885
FDA 510(k) database 510(k) number K202156
FDA 510(k) database 510(k) number K192453

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 88000111DSDIA4000GM registered 21 May 2026 Active
FDA 510(k) K202156 decided 10 Sep 2020 Active· +1 more in the status table
FDA GUDID UDI-DI 08800011140151 listed 29 May 2017 Listed

Timeline

4 dated events

29 May 2017 Listed FDA GUDID 08800011140151
1 Oct 2019 Cleared FDA 510(k) K192453
10 Sep 2020 Cleared FDA 510(k) K202156
21 May 2026 Registered EUDAMED 88000111DSDIA4000GM

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Diamond-5A EUDAMED
Drgem GUDID
Generic name: Stationary basic diagnostic x-ray system, digital
Device name: Digital diagnostic X-ray System
Model / reference: DIAMOND-5A, DIAMOND-6A, DIAMOND-8A

Primary DI / UDI-DI: 08800011140151, 08800011140007, 08800011140885, 08800011140892
Basic UDI-DI: 88000111DSDIA4000GM
510(k) Number: K192453
K202156
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
EU registration type: Standard device
EU market of registration: Poland
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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.

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

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See all devices from DRGEM Corporation →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (22, all answered No)