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Yushan V17Ge

by InnoCare Optoelectronics Corp. Taiwan EUDAMEDGUDID

Ref 04719879300055, Yushan V17GeModel V14C, V14G, V17C, V17G, V17Ce, V17Ge, F14C, F14G Product code MQBEMDN Z11031180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number471987930YushanVFE9 Basic UDI-DIDate29 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number471987930YushanVFE9 Basic UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719879300055 UDI-DIDate3 Nov 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Yushan V17Ge EUDAMED
V17Ge EUDAMED
Yushan GUDID
Generic Name
Stationary basic diagnostic x-ray system, digital
Device Name
Yushan X-ray Flat Panel Detector
Yushan Flat Panel Detector
Model / Reference
V14C, V14G, V17C, V17G, V17Ce, V17Ge, F14C, F14G, 04719879300055, Yushan V17Ge
Primary DI / UDI-DI
04719879300055
Basic UDI-DI
471987930YushanVFE9, B-04719879300055
510(k) Number
FDA Product Code
MQB
EMDN Code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
GMDN Term
Stationary basic diagnostic x-ray system, digital
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1680
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
V14C, V14G, V17C, V17G, V17Ce, V17Ge, F14C, F14G
04719879300055
Yushan V17Ge
GUDID
V17Ge
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000008789
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from InnoCare Optoelectronics Corp.

See all devices from InnoCare Optoelectronics Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED bc859373-04cd-4fe9-a59d-891bc889c40d 61 fields · synced 23 Oct 2026
  • FDA UDI ef5d928c-6087-4975-979f-3c83a0e99ee3 33 fields · synced 30 May 2026
  • EUDAMED 04719879300055|B-04719879300055 61 fields · synced 6 Oct 2026