Olympus

FDA UDI

Class II (US FDA UDI)

by Keymed (Medical & Industrial Equipment), Ltd.

Identity

Trade Name: Olympus FDA UDI
Generic Name: Endoscopic irrigation/aspiration pump FDA UDI
Model / Reference: MAJ-1603 FDA UDI

Identifiers

Primary DI / UDI-DI: 15019778003344 FDA UDI
FDA Product Code: FEQ FDA UDI
GMDN Term: Endoscopic irrigation/aspiration pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic irrigation/aspiration pump

Olympus by Keymed (Medical & Industrial Equipment), Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic irrigation/aspiration pump.

Stabilisation disc — SOPRO-COMEG GmbH · Class II
RocaFlow II - Double Chamber with Aspiration Pump — Promepla · Class II
Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
RocaFlow II - Simple Chamber — Promepla · Class II
LAP-Pump — W.O.M. World of Medicine GmbH · Class II
Stabilisation disc — SOPRO-COMEG GmbH · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Keymed (Medical & Industrial Equipment), Ltd.

Sources (1)

FDA UDI b4b44478-1ccb-4525-8392-60d170fb1332 32 fields · synced Jun 8, 2026