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Me04kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ME04KITModel ME03KIT

by Case Medical, Inc.

Identity

Trade Name
ME04KIT EUDAMED
CASE MEDICAL FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
ME03KIT EUDAMED
MEDICAL ENTERPRISES BATTERY TRAY DISPOSABLE KIT FDA UDI
Model / Reference
ME03KIT EUDAMED
ME04KIT EUDAMEDFDA UDI
Description
MEDICAL ENTERPRISES BATTERY TRAY DISPOSABLE KIT FDA UDI

Identifiers

Catalog Number
ME04KIT FDA UDI
Primary DI / UDI-DI
00653159014147 EUDAMED
00653159008139 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Me04kit by Case Medical Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

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

Sources (2)

  • EUDAMED 2374adf5-f79c-47d5-bd0b-2ab0b0c0be10 61 fields · synced Jun 18, 2026
  • FDA UDI 3692a9ad-66a2-4a8e-9faa-75d1b3e1a047 34 fields · synced May 30, 2026