Keratograph 5M

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: Keratograph 5M FDA UDI
Generic Name: Corneal topography system FDA UDI
Device Name: The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is reflected off the cornea. These data are analyzed by the computer. FDA UDI
Model / Reference: 7700 FDA UDI
Description: The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is reflected off the cornea. These data are analyzed by the computer. FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584000477 FDA UDI
FDA Product Code: MMQ FDA UDI
GMDN Term: Corneal topography system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1350 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

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 6.1 Kilogram FDA UDI
Height — 512 Millimeter FDA UDI
Depth — 400 Millimeter FDA UDI
Width — 275 Millimeter FDA UDI

Category: Corneal topography system

Keratograph 5M by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Corneal topography system.

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MYOPIA EXPERT 700 — VISIA IMAGING SRL · Class II
MYAH — VISIA IMAGING SRL · Class II
WAVELIGHT ALLEGRO TOPOLYZER — Alcon Laboratories, Inc. · Class III
WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
Topographic Modeling System — Tomey Corporation · Class I
CASSINI — Cassini Technologies B.V. · Class I

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: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI 1ca9393f-84b4-4601-afd6-6ef12318353a 35 fields · synced Jun 8, 2026