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MammoScape

by MeVis Medical Solutions AG

Ref EIRA-1.2.Model 1.x

MammoScape (EIRA-1.2.) is a Class IIa device made by Mevis Medical Solutions AG, registered in EUDAMED on 6 Feb 2026 (Basic UDI-DI 0426048329EIRAT6), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0426048329EIRAT6 Basic UDI-DI 04260483290329UDI-DIDate6 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
MammoScape
Model / reference
1.x, EIRA-1.2.
Primary DI / UDI-DI
04260483290329
Basic UDI-DI
0426048329EIRAT6
Direct marketing DI
04260483290329
EMDN code
Z11030592 Radiology instruments - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005418

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Mevis Medical Solutions AG

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Properties

  • Measuring function
Other properties (13, all answered No)