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Carl Zeiss Ophthalmic Systems, Inc.

USA · Washington

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

71listed device types

Class I 39Class II 29Class III 3

plus 215 registration records and 137 510(k), 125 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

49registered devices

Class I 27Class II 22

100 including historic records

SASaudi ArabiaSFDA

32registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

21active device licences

Class II 18Class III 3

79 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States215 registration records, 137 510(k), 125 PMA, 2 excluded

Brazil49 confirmed, 0 excluded

Saudi Arabia32 confirmed, 0 excluded

Canada21 confirmed, 0 excluded

Manufacturer names merged into this page: CARL ZEISS MEDITEC AG (JENA) · Carl Zeiss Meditec AG (Jena) · Carl Zeiss Meditec Production, LLC. · CARL ZEISS MEDITEC INC · CARL ZEISS MEDITEC INC. · CARL ZEISS SURGICAL GMBH

Same-named companies — This database also contains companies with near-identical names: Carl Zeiss, Inc., CARL ZEISS DO BRASIL LTDA, CARL ZEISS CANADA LTD., Carl Zeiss Meditec, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12006

22007

52009

52010

12011

52012

42013

52014

32015

22016

72017

72018

62019

32020

12021

52022

82023

42024

42025

22026

FDA listed device types

showing 8 of 71

Tonometer, Ac-Powered 1Transilluminator, Ac-Powered 1Ophthalmoscope, Ac-Powered 1Drape, Microscope, Ophthalmic 1Whole Slide Imaging System 1Drape, Surgical, Exempt 1System, Image Management, Ophthalmic 1Unit, Phacofragmentation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260694	ZEISS CLINIC 360	2026-07-17
US	K253834	VISUREF 600	2026-03-18
US	K243395	MICOR 700 with Auto I/A	2025-08-08
BR	10332030043	CAPA OPMI (OPMI DRAPES)	Class I
BR	10332030140	ZEISS Surgery Planner	Class II
BR	10332039094	I/A TUBING SET, REUSABLE	Class II
SA	ME0000003677SFDAA00002	OPMI LUMERA 300	—
SA	ME0000003677SFDAA00008	Fluorescence Mode	—
CA	6248	HUMPHREY MASTERVUE CORNEAL TOPOGRAPHY SYSTEM	Class II
CA	6872	HUMPHREY ULTRASOUND BIOMETER	Class II
CA	8885	HUMPHREY ULTRASOUND BIOMICROSCOPE	Class II

Carl Zeiss Ophthalmic Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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