EleVision™

FDA UDI

Class II (US FDA UDI)

by SCHÖLLY FIBEROPTIC GmbH

Identity

Trade Name: EleVision™ FDA UDI
Generic Name: Endoscopic light source unit, line-powered FDA UDI
Device Name: EleVision TM LED Light Source FDA UDI
Model / Reference: ELEVLED FDA UDI
Description: EleVision TM LED Light Source FDA UDI

Identifiers

Primary DI / UDI-DI: 04250480113677 FDA UDI
FDA Product Code: NTN FDA UDI
GMDN Term: Endoscopic light source unit, line-powered 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endoscopic light source unit, line-powered

EleVision™ by SCHÖLLY FIBEROPTIC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LED 610 Light source — Erbe Vision GmbH · Class I
SPOTLIGHT — Depuy Spine, Inc. · Class II
SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
FUJIFILM — FUJIFILM Corporation · 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: SCHÖLLY FIBEROPTIC GmbH

Sources (1)

FDA UDI b6bfbe46-85b6-4adf-823a-4cbad386b9cb 35 fields · synced May 30, 2026