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ML7 Sterilization Tray

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 1500ML7

by Med-Logics, Inc.

Identity

Trade Name
Sterilization Tray, ML7 FDA UDI
Generic Name
Microkeratome FDA UDI
Device Name
ML7 Sterilization Tray EUDAMED
Sterilization tray for use with the ML7 microkeratome FDA UDI
Model / Reference
1500ML7 EUDAMEDFDA UDI
Description
Sterilization tray for use with the ML7 microkeratome FDA UDI

Identifiers

Catalog Number
1500ML7 FDA UDI
Primary DI / UDI-DI
00850724001810 EUDAMEDFDA UDI
Basic UDI-DI
B-00850724001810 EUDAMED
FDA Product Code
HNO FDA UDI
EMDN Code
Z1212020580 MICROKERATOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Microkeratome FDA 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

ML7 Sterilization Tray by Med Logics Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 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 1d6bb514-2bee-4bc7-97a2-f0b868cf53d3 61 fields · synced Jul 11, 2026
  • FDA UDI c7fa6b97-7d35-481c-9c20-be19b839735e 35 fields · synced May 30, 2026