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2520CE

by Medical Instrument Development Laboratories, Inc.

Ref 2520CE

2520CE is a vitrectomy system micro-cutting unit (EU MDD Class IIa; FDA Class II; FDA product code HQE, Instrument, Vitreous Aspiration And Cutting, Ac-Powered) made by Medical Instrument Development Laboratories, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-10812480010120) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 10812480010120), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10812480010120 Basic UDI-DI 10812480010120UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10812480010120 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10812480010120 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 10812480010120 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10812480010120
  2. Registered EUDAMED B-10812480010120

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  • Withdrawn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
Vitreous Cutter
Generic name
Vitrectomy system micro-cutting unit
Model / Ref / Catalog
2520CE
Primary DI / UDI-DI
10812480010120 EUDAMED
00812480010123 GUDID
Basic UDI-DI
B-10812480010120
FDA product code
HQE
EMDN code
Q020499 Vitrectomy devices - other
GMDN term
Vitrectomy system micro-cutting unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 23 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10812480010120
GUDID
00812480010123
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10812480010120; FDA GUDID lists 00812480010123), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vitrectomy system micro-cutting unit

Similar devices in this category

Other devices filed under VITRECTOMY DEVICES - OTHER.

Other devices from Medical Instrument Development Laboratories, Inc.

See all devices from Medical Instrument Development Laboratories, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)