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Beaver® 0009722

by Beaver-Visitec International Inc

Ref 0009722

Beaver® 0009722 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-00886158011316) and listed in FDA GUDID since 27 Jun 2024 (UDI-DI 00886158011316), 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-00886158011316 Basic UDI-DI 00886158011316UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158011316 UDI-DI Date27 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158011316 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158011316 listed 27 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158011316
  2. Registered EUDAMED B-00886158011316

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  • Withdrawn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
Beaver®
Generic name
Corneal trephine, single-use
Device name
Ophthalmic Trephine Blades
Model / Ref / Catalog
0009722
Primary DI / UDI-DI
00886158011316 EUDAMED
30886158011317 GUDID
Basic UDI-DI
B-00886158011316
FDA product code
HRH
EMDN code
Q020201 Corneal punches and trephines, single-use
GMDN term
Corneal trephine, 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
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158011316
GUDID
30886158011317
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00886158011316; FDA GUDID lists 30886158011317), 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: Corneal trephine, single-use

Similar devices in this category

Other devices filed under DEVICES FOR CORNEA EXPLANTATION AND TRANSPLANTATION.

Other devices from Beaver-Visitec International Inc

See all devices from Beaver-Visitec International Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
Other properties (22, all answered No)