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MammoScape

by MeVis BreastCare GmbH & Co. KG (merged into Actor with SRN: DE-MF-000005418)

Ref EIRA-1.1.0Model 1.x

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04262459510028 UDI-DI Date4 Mar 2025ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number0426245951EIRAUU Basic UDI-DI 04262459510028UDI-DIDate26 Feb 2025RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Diagnostic x-ray digital imaging system workstation application software
Model / Reference
1.x EUDAMED
EIRA-1.1.0 EUDAMED
1.1.x GUDID
Primary DI / UDI-DI
04262459510028
Basic UDI-DI
0426245951EIRAUU
Direct Marketing DI
04262459510028
FDA Product Code
LMD
EMDN Code
Z11030592 Radiology instruments - medical device software
GMDN Term
Diagnostic x-ray digital imaging system workstation application software
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
892.2020
Special Device Type
Software
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1.x
EIRA-1.1.0
GUDID
1.1.x
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000042658

Properties

  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No