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Suction irrigation set

by Unimax Medical Systems Inc. 5 variants

Ref FSI13310C

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04714127869216 Basic UDI-DI 04714127869216UDI-DIDate8 Sep 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Suction irrigation set
Model / Reference
FSI13310C
Primary DI / UDI-DI
04714127869216
Basic UDI-DI
B-04714127869216
EMDN Code
Z12019099 Various instruments for general and multidisciplinary surgery - other
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
TW-MF-000008895
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Unimax Medical Systems Inc.

See all devices from Unimax Medical Systems Inc. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No