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Visitec® 585036

by Beaver-Visitec International Inc

Ref 585036

Visitec® 585036 is a device classified as Class IIa in the EU and Class I in the US made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00886158006527) and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 00886158006527), active as of 8 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00886158006527 Basic UDI-DI 00886158006527UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158006527 UDI-DI Date1 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158006527 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158006527 listed 1 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158006527
  2. Registered EUDAMED B-00886158006527

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Visitec®
Generic name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device name
Ophthalmic Hydrodissection Cannulas
Model / Ref / Catalog
585036
Description
Nucleus Hydrodissector [Pearce] .40 x 22mm (27G x 7/8in) 10
Primary DI / UDI-DI
00886158006527 EUDAMED
30886158006528 GUDID
Basic UDI-DI
B-00886158006527
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
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158006527
GUDID
30886158006528
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00886158006527; FDA GUDID lists 30886158006528), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Similar devices in this category

Other devices filed under OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE.

Other devices from Beaver-Visitec International Inc

See all devices from Beaver-Visitec International Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)