Skip to content

Drypro Sigma A4AA

by Konica Minolta, Inc.

Ref A4AAModel DRYPRO SIGMA

Drypro Sigma A4AA is a device classified as Class I in the EU and Class II in the US made by Konica Minolta, Inc., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 4560141920000488M) and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 04560141932494), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4560141920000488M Basic UDI-DI 04560141932494UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141932494 UDI-DI Date5 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4560141920000488M registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 04560141932494 listed 5 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04560141932494
  2. Registered EUDAMED 4560141920000488M

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  • Withdrawn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
Drypro Sigma
Generic name
Diagnostic-imaging multiformat camera
Model / reference
A4AA, DRYPRO SIGMA
Primary DI / UDI-DI
04560141932494
Basic UDI-DI
4560141920000488M
Direct marketing DI
04560141932494
FDA product code
LMC
EMDN code
Z110705 Laser imagers for bioimaging
GMDN term
Diagnostic-imaging multiformat camera
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2040
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 X–RAY FILM IMAGING SUPPORT INSTRUMENTS.

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

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