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MAMMOVISTA B.smart VB7

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11647802Model MDR_18_II b_ERLN H 127_WHSAMD

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686901980WF Basic UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869299297 UDI-DIDate16 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MAMMOVISTA B.smart
Generic Name
Diagnostic x-ray digital imaging system workstation application software
Device Name
MDR_18_II b_ERLN H 127_WHSAMD
Model / Reference
MDR_18_II b_ERLN H 127_WHSAMD EUDAMED
11647802 EUDAMED
VB7 GUDID
Primary DI / UDI-DI
04056869299297
Basic UDI-DI
0405686901980WF
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11030292 Mammography systems - medical device software
GMDN Term
Diagnostic x-ray digital imaging system workstation application software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MDR_18_II b_ERLN H 127_WHSAMD
11647802
GUDID
VB7
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

Other properties (24)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No