Visupac 500

FDA UDI

Class I (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name: VISUPAC 500 FDA UDI
Generic Name: Posterior eye segment analyser software FDA UDI
Device Name: The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented. FDA UDI
Model / Reference: VISUPAC 500 FDA UDI
Description: The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented. FDA UDI

Identifiers

Primary DI / UDI-DI: 04049471094077 FDA UDI
FDA Product Code: NFG FDA UDI
NFF FDA UDI
GMDN Term: Posterior eye segment analyser software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.2020 FDA UDI
892.2010 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Height — 400 Millimeter FDA UDI
Weight — 14 Kilogram FDA UDI

Category: Posterior eye segment analyser software

Visupac 500 by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Posterior eye segment analyser software.

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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: Carl Zeiss Meditec AG

Sources (1)

FDA UDI 00e8f49f-398c-4d74-bd68-4da4468a7777 35 fields · synced Jun 1, 2026