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KARL STORZ GMBH & CO. KG

Germany

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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

223listed device types

Class I 110Class II 110Class III 2unclassified 1

plus 2,528 registration records and 452 510(k), 46 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

167registered devices

Class I 88Class II 79

181 including historic records

SASaudi ArabiaSFDA

785registered imported devices

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

CACanadaMDALL

143active device licences

Class II 122Class III 11Class IV 10

339 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

23active ARTG entries

Class I 16IIa 3IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States2,528 registration records, 452 510(k), 46 PMA, 6 excluded

Brazil167 confirmed, 1 excluded

Saudi Arabia785 confirmed, 3 excluded

Canada143 confirmed, 0 excluded

Manufacturer names merged into this page: KARL STORZ SE & CO. KG · KARL STORZ SE & CO KG · KARL STORZ ENDOSCOPY-AMERICA, INC. · Karl Storz Endoscopy-America, Inc. · KARL STORZ GMBH & CO · KARL STORZ ENDOSCOPIA BRASIL LTDA

Same-named companies — This database also contains companies with near-identical names: Karl Storz Endoscopy, KARL STORZ ENDOSCOPY CANADA LTD., KARL STORZ IMAGING, INC., KARL STORZ SE & CO. KG. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

112007

42008

52009

32010

22011

52012

42013

42014

32015

52016

82017

52018

52019

122020

82021

52022

92023

72024

72025

72026

FDA listed device types

showing 8 of 223

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Guidewire, Gastroenterology-Urology 1Drape, Microscope, Ophthalmic 1Proctoscope 1Lithotriptor, Biliary Mechanical 1Light, Surgical, Accessories 1Clamp, Vascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261706	Endomat Select (UP220)	2026-07-16
US	K252800	KARL STORZ Endoscopic Accessories for Urology	2026-06-03
US	K252624	KARL STORZ Laryngoscopes and Accessories	2026-05-15
BR	10302860253	Lâminas	Class II
BR	80753460126	IMAGE1	Class I
BR	80753460003	Espéculo de Uso Único KARL STORZ	Class I
SA	ME0000003576SFDAA01074	Cold Knife	—
SA	ME0000003576SFDAA01079	Sleeve	—
CA	14346	CHAVANTES-ZAMORANO NEURO-ENDOSCOPES	Class IV
CA	60915	TRACHEOSTOMY TRACHEA TUBES	Class II
CA	63829	DISPOSABLE TONSILLECTOMY/ADENOID SETS	Class II

KARL STORZ GMBH & CO. KG

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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