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Clb®

by Med-Logics, Inc. 39 variants

Ref ML7030 (-10)

Clb® (ML7030 (-10)) is a device classified as Class IIa in the EU and Class I in the US made by Med Logics Inc, registered in EUDAMED on 17 Jan 2024 (Basic UDI-DI B-10850724001039), cleared under FDA 510(k) K010872 on 22 Jun 2001 and listed in FDA GUDID since 21 Jul 2020 (UDI-DI 10850724001039), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K010872

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10850724001039 Basic UDI-DI 10850724001039UDI-DIDate17 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10850724001039 UDI-DI Date21 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010872 Date22 Jun 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10850724001039 registered 17 Jan 2024 Active
  • FDA 510(k) K010872 decided 22 Jun 2001 Active
  • FDA GUDID UDI-DI 10850724001039 listed 21 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010872
  2. Listed FDA GUDID 10850724001039
  3. Registered EUDAMED B-10850724001039

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  • Withdrawn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
Clb® EUDAMED
ML7030 (Minus 10) GUDID
Generic name
Keratome blade, single-use
Model / Ref / Catalog
ML7030 (-10)
Primary DI / UDI-DI
10850724001039 EUDAMED
00850724001032 GUDID
Basic UDI-DI
B-10850724001039
510(k) Number
FDA product code
HNO
EMDN code
Z1212020585 Microkeratomy instruments - consumables
GMDN term
Keratome blade, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4370
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10850724001039
GUDID
00850724001032
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 10850724001039; FDA GUDID lists 00850724001032), 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.

Manufacturer details

EUDAMED SRN
US-MF-000004600
Authorised representative
E C REP LIMITED IE-AR-000003995

Related devices

Category: Corneal punch set

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MICROKERATOME SURGERY.

Other devices from Med Logics Inc

See all devices from Med Logics Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)