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Microsharp® 377546

by Beaver-Visitec International Inc

Ref 377546

Microsharp® 377546 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-00886158001515) and listed in FDA GUDID since 6 Jun 2024 (UDI-DI 00886158001515), 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-00886158001515 Basic UDI-DI 00886158001515UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158001515 UDI-DI Date6 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158001515 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158001515 listed 6 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158001515
  2. Registered EUDAMED B-00886158001515

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  • Withdrawn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
Microsharp®
Generic name
Ophthalmic knife, single-use
Device name
General Ophthalmic Knives & Blades
Model / Ref / Catalog
377546
Primary DI / UDI-DI
00886158001515 EUDAMED
30886158001516 GUDID
Basic UDI-DI
B-00886158001515
FDA product code
HNN
EMDN code
Q02010101 Ophthalmic microknives, straight
GMDN term
Ophthalmic knife, 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
Radiation Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158001515
GUDID
30886158001516
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 00886158001515; FDA GUDID lists 30886158001516), 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 knife, single-use

Similar devices in this category

Other devices filed under OPHTHALMIC MICROKNIVES, STRAIGHT.

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)