Mydriatic Hyperspectral Retinal Camera

FDA UDI

Class II (US FDA UDI)

by Optina Diagnostiques, Inc

Identity

Trade Name: Mydriatic Hyperspectral Retinal Camera FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) FDA UDI
Model / Reference: MHRC-C1 FDA UDI
Description: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) FDA UDI

Identifiers

Primary DI / UDI-DI: 00627987702125 FDA UDI
510(k) Number: K200254 FDA UDI
FDA Product Code: HKI FDA UDI
NFJ FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 FDA UDI
892.2050 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: Ophthalmic fundus camera

Mydriatic Hyperspectral Retinal Camera by Optina Diagnostiques, Inc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Optina Diagnostiques, Inc

Sources (1)

FDA UDI 02ed2d55-fa38-428a-86d4-d980ffd56b54 34 fields · synced Jun 8, 2026