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Bi-Blade® 2340BB

by Medical Instrument Development Laboratories, Inc.

Ref 2340BB

Bi-Blade 2340BB 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-10812480010755), cleared under FDA 510(k) K153168 on 29 Apr 2016 and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10812480010755), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153168

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10812480010755 Basic UDI-DI 10812480010755UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10812480010755 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK153168 Date29 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10812480010755 registered 21 Oct 2026 Active
  • FDA 510(k) K153168 decided 29 Apr 2016 Active
  • FDA GUDID UDI-DI 10812480010755 listed 24 Sep 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153168
  2. Listed FDA GUDID 10812480010755
  3. Registered EUDAMED B-10812480010755

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vitreous Cutter EUDAMED
Bi-Blade® GUDID
Generic name
Vitrectomy system micro-cutting unit
Model / Ref / Catalog
2340BB
Primary DI / UDI-DI
10812480010755 EUDAMED
00812480010758 GUDID
Basic UDI-DI
B-10812480010755
510(k) Number
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 — 25 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10812480010755
GUDID
00812480010758
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10812480010755; FDA GUDID lists 00812480010758), 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

Cleared under the same submission (K153168)

and 8 more cleared under K153168

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)