Rechargeable Light Source

FDA UDIEUDAMED

Class I (US FDA UDI)

by Bionix, LLC

Identity

Trade Name: Rechargeable Light Source FDA UDI
Generic Name: ENT instrument light source FDA UDI
Device Name: Rechargeable Light Source with Magnification Lens FDA UDI
Model / Reference: 3600 FDA UDI
Description: Rechargeable Light Source with Magnification Lens FDA UDI

Identifiers

Catalog Number: 3600 FDA UDI
Primary DI / UDI-DI: 00714646001375 FDA UDI
FDA Product Code: KYT FDA UDI
GMDN Term: ENT instrument light source FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6350 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ENT instrument light source

Rechargeable Light Source by Bionix, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as ENT instrument light source.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bionix, LLC

Sources (2)

FDA UDI 48458b23-6ee7-47f7-953e-ee1288b8205f 35 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 3, 2026