Illuminix

FDA UDI

Class I (US FDA UDI)

by Illuminix Industries LLC

Identity

Trade Name: ILLUMINIX FDA UDI
Generic Name: Ophthalmic examination station FDA UDI
Device Name: Chair with motorized elevation and reclining for patient still seated for eye refraction examination FDA UDI
Model / Reference: ORBIT COMFORT FDA UDI
Description: Chair with motorized elevation and reclining for patient still seated for eye refraction examination FDA UDI

Identifiers

Primary DI / UDI-DI: 00860010833216 FDA UDI
FDA Product Code: HME FDA UDI
GMDN Term: Ophthalmic examination station FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1140 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic examination station

Illuminix by Illuminix Industries LLC — 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: Illuminix Industries LLC

Sources (1)

FDA UDI 5ae81390-72fd-4c80-827c-013f81e30fe2 34 fields · synced May 30, 2026