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Led Light Source

FDA UDI

Class I (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
LED LIGHT SOURCE FDA UDI
Generic Name
Microscope light source FDA UDI
Model / Reference
OME-L200 FDA UDI

Identifiers

Primary DI / UDI-DI
04953170395901 FDA UDI
FDA Product Code
EPT FDA UDI
IZI FDA UDI
GMDN Term
Microscope light source 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microscope light source

Led Light Source by Olympus Medical Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microscope light source.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI e85afa88-837f-4f6b-b67d-aafb41b76cd8 33 fields · synced May 30, 2026