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ML7 Head; 130µm

by Med-Logics, Inc.

Ref 0130ML7

ML7 Head +1 more model (0130ML7) is a microkeratome (EU MDD Class IIa; FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Med Logics Inc, registered in EUDAMED on 17 Jan 2024 (Basic UDI-DI B-00850724001834) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI 00850724001834), 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-00850724001834 Basic UDI-DI 00850724001834UDI-DIDate17 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850724001834 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850724001834 registered 17 Jan 2024 Active
  • FDA GUDID UDI-DI 00850724001834 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850724001834
  2. Registered EUDAMED B-00850724001834

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  • Withdrawn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
Head, ML7, 130 Micron
Generic name
Microkeratome
Device name
ML7 Head; 130µm
Model / Ref / Catalog
0130ML7
Primary DI / UDI-DI
00850724001834
Basic UDI-DI
B-00850724001834
FDA product code
HNO
EMDN code
Z1212020580 Microkeratomy instruments - hardware accessories
GMDN term
Microkeratome
Models / Variants
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4370
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MICROKERATOME SURGERY.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)