Skip to content

Irrigation Line 32.F0139.00

by Omnia Spa EUDAMEDGUDID

Active European Union

Ref 32.F0139.00

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08052141311806 Basic UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052141311806 UDI-DIDate27 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Irrigation Line
Generic Name
Disposable surgical irrigation/aspiration system
Device Name
Sterile Hose Sets for Machinery and Accessories
Model / Reference
32.F0139.00
Primary DI / UDI-DI
08052141311806
Basic UDI-DI
B-08052141311806
FDA Product Code
EFS
EMDN Code
A03040299 Irrigation kits, single-use - other
GMDN Term
Disposable surgical irrigation/aspiration system
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.6510
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Omnia Spa

See all devices from Omnia Spa →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No