Me03kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ME03KIT

by Case Medical, Inc.

Identity

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

Identifiers

Catalog Number: ME03KIT FDA UDI
Primary DI / UDI-DI: 00653159014130 EUDAMED
00653159008122 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

Me03kit by Case Medical Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument tray, reusable.

MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (2)

EUDAMED 734740d0-37fe-4534-a5cf-e072c16c4ad9 61 fields · synced Jul 22, 2026
FDA UDI a6c36b3e-2b51-4479-ab18-572f5eef64bd 34 fields · synced May 30, 2026