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Yushan V17C

by InnoCare Optoelectronics Corp. Taiwan EUDAMEDGUDID

Ref 04719879300031, Yushan V17CModel V14C, V14G, V17C, V17G, V17Ce, V17Ge, F14C, F14G Product code MQBEMDN Z11031180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471987930YushanVFE9 Basic UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719879300031 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/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Yushan V17C EUDAMED
V17C 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, 04719879300031, Yushan V17C
Primary DI / UDI-DI
04719879300031
Basic UDI-DI
471987930YushanVFE9, B-04719879300031
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
04719879300031
Yushan V17C
GUDID
V17C
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 b69b4865-fea9-4fca-a2c1-7c31ea0033ba 61 fields · synced 24 Oct 2026
  • FDA UDI e2aa2630-4e90-4164-90ca-78946a87375e 33 fields · synced 29 May 2026
  • EUDAMED 04719879300031|B-04719879300031 61 fields · synced 10 Jul 2026