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ML7 Head - 130µm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 0130ML7

by Med-Logics, Inc.

Identity

Trade Name
Head, ML7, 130 Micron FDA UDI
Generic Name
Microkeratome FDA UDI
Device Name
ML7 Head; 130µm EUDAMED
130 Micron Head for use with the ML7 Microkeratome FDA UDI
Model / Reference
0130ML7 EUDAMEDFDA UDI
Description
130 Micron Head for use with the ML7 Microkeratome FDA UDI

Identifiers

Catalog Number
0130ML7 FDA UDI
Primary DI / UDI-DI
00850724001834 EUDAMEDFDA UDI
Basic UDI-DI
B-00850724001834 EUDAMED
FDA Product Code
HNO FDA UDI
EMDN Code
Z1212020580 MICROKERATOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Microkeratome FDA UDI
Models / Variants
ML7 Head EUDAMEDFDA UDI
130µm EUDAMEDFDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
886.4370 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

ML7 Head - 130µm by Med Logics Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med-Logics, Inc.
EUDAMED SRN
US-MF-000004600
Authorised Representative
E C REP LIMITED IE-AR-000003995

Sources (2)

  • EUDAMED d46daa8a-8fc7-4051-be1d-43726284ad09 61 fields · synced Jun 18, 2026
  • FDA UDI 687a1637-689b-4baf-a106-283aa35d83e0 35 fields · synced May 30, 2026