Me05kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ME05KITModel ME03KIT

by Case Medical, Inc.

Identity

Trade Name: ME05KIT EUDAMED
CASE MEDICAL FDA UDI
Generic Name: Device sterilization/disinfection container, reusable FDA UDI
Device Name: ME03KIT EUDAMED
MEDICAL ENTERPRISES ADAPTER TRAY DISPOSABLE KIT FDA UDI
Model / Reference: ME03KIT EUDAMED
ME05KIT EUDAMEDFDA UDI
Description: MEDICAL ENTERPRISES ADAPTER TRAY DISPOSABLE KIT FDA UDI

Identifiers

Catalog Number: ME05KIT FDA UDI
Primary DI / UDI-DI: 00653159014154 EUDAMED
00653159008146 FDA UDI
Basic UDI-DI: 0653159SC0009KITCL EUDAMED
EMDN Code: S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
GMDN Term: Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Medical Purpose: Additional accessories for the system - ME03 EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument tray, reusable

Me05kit by Case Medical Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Instrument tray, reusable.

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ASELTECH — Asel Tibbi Aletler A.S. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0653159SC0009KITCL	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Case Medical, Inc.
EUDAMED SRN: US-PR-000053042

Sources (2)

EUDAMED e4bbcf4f-d149-4044-93c3-5189419a62a2 61 fields · synced Jul 10, 2026
FDA UDI 1b75bae1-4159-4965-b70b-4ff9ad9a7beb 34 fields · synced May 30, 2026