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[Simcoe] Double Barrel I/A Cannula 23g/23g Thin Wall, side port

by PSI/EYE-KO, Inc. EUDAMEDGUDID

Active European Union

Ref 3003TWModel I/A Cannulas and Cortex Removal

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840516145983 UDI-DIDate3 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0840516130004N Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR 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
[Simcoe] Double Barrel I/A Cannula 23g/23g Thin Wall, side port EUDAMED
Anodyne Surgical GUDID
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Model / Reference
I/A Cannulas and Cortex Removal, 3003TW
Primary DI / UDI-DI
00840516145983, 00840516146010
Basic UDI-DI
0840516130004N
FDA Product Code
HMX
EMDN Code
Q021101 Occular irrigation and aspiration cannulas, single-use
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
No
GUDID
No
Yes

Manufacturer details

EUDAMED SRN
US-MF-000022109
Authorised representative
Advena SRL IT-AR-000051131

Other devices from Psi/Eye-Ko, Inc.

See all devices from Psi/Eye-Ko, Inc. →

Properties

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

Other properties (17)

  • 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