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Tubing set Faros/CataRhex 3/Swisstech

by Oertli Instrumente AG 2 variants

Ref VV621010Model MD0105.02 Tubing Sets Single Pump System Single Use

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300039MD010502SY Basic UDI-DI 07630003904390UDI-DIDate26 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630003904390 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Tubing set Faros/CataRhex 3/Swisstech EUDAMED
Oertli® GUDID
Generic Name
Surgical irrigation/aspiration tubing set
Model / Reference
MD0105.02 Tubing Sets Single Pump System Single Use, VV621010
Primary DI / UDI-DI
07630003904390
Basic UDI-DI
76300039MD010502SY
FDA Product Code
HQC
EMDN Code
Q020499, Q020699
GMDN Term
Surgical irrigation/aspiration tubing set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.4670
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000016175
Authorised representative
Oertli Ophthalmedic Österreich GmbH AT-AR-000003554

Other devices from Oertli Instrumente AG

See all devices from Oertli Instrumente AG →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Premarket Exempt: No
  • Serial Number: No