Auto Focus Unit

FDA UDI

Class I (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: AUTO FOCUS UNIT FDA UDI
Generic Name: Software upgrade/unlocking key FDA UDI
Model / Reference: MAJ-2303 FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170395963 FDA UDI
FDA Product Code: EPT FDA UDI
IZI FDA UDI
GMDN Term: Software upgrade/unlocking key FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4700 FDA UDI
892.1600 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Software upgrade/unlocking key

Auto Focus Unit by Olympus Medical Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI ad44b3e4-f732-406a-b3ad-1cb27c5ab855 33 fields · synced May 30, 2026