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Fv-1321SH.

by Ordisi, S.A

Ref FV-1321SH.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84352050ASPackQU Basic UDI-DI 84352050278116UDI-DIDate25 Aug 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  • Withdrawn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
Aspirator Series
Model / Reference
FV-1321SH.
Primary DI / UDI-DI
84352050278116
Basic UDI-DI
84352050ASPackQU
EMDN Code
Z120105 Surgical medical aspirators
Device Class
Class IIa
Medical Purpose
The Aspirator Series is a family of operating room aspirators and portable aspirators with continuous or intermittent suction intended to empty a zone from body fluids during major surgery, medium surgery, endoscopic aspiration, gynecological aspiration, operating room aspiration or gastric aspiration. It is intended to be used in patients who need the extraction of corporal fluids (blood, intestinal fluids, urine, saliva, etc.) by healthcare professionals in Operating rooms, ICUs, mobile ICUs, and treatment rooms.

Manufacturer details

EUDAMED SRN
ES-PR-000000988

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Properties

Other properties (1)

  • Sterile: No