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Sistema Sirevix vers. DRF

by GMS MED s.r.l.

Ref 8500200Model Sistema Sirevix vers. DRF

Active European Union

CE MDR

Valid until

Not listed

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

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805361067SIRE100HC Basic UDI-DI 08053610670110UDI-DIDate31 Jul 2026RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sistema Radiologico Telecomandato Digitale
Model / Reference
Sistema Sirevix vers. DRF, 8500200
Primary DI / UDI-DI
08053610670110
Basic UDI-DI
805361067SIRE100HC
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIb
Medical Purpose
Digital radiological system intended for diagnostic radiographic and fluoroscopic examinations on adult and pediatric patients.

Manufacturer details

EUDAMED SRN
IT-PR-000028736

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Properties

Other properties (1)

  • Sterile: No