STORZ MEDICAL AG

Switzerland · Tagerwilen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

9listed device types

Class I 2Class II 6Class III 1

plus 33 registration records and 3 510(k), 2 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 1Class III 2

27 including historic records

TWTaiwanTFDA

15valid device licences

Class II 4Class III 11

SGSingaporeHSA SMDR

9device registrations

CLASS B 3CLASS C 6

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

4active ARTG entries

IIa 3IIb 1

HKHong KongMDACS

7valid listings

Class II 3Class III 4

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 6Class 2b 3

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 States33 registration records, 3 510(k), 2 PMA, 33 excluded

Brazil2 confirmed, 6 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada3 confirmed, 4 excluded

Manufacturer names merged into this page: STORZ MEDICAL AG · STORZ MEDICAL AMERICA, INC.

FDA 510(k) clearances by year

12018 · K173692

22021 · K203710

FDA listed device types

showing 8 of 9

Stimulator, Muscle, Powered 1System, Image Processing, Radiological 1Lithotriptor, Extracorporeal Shock-Wave, Urological 1Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers 1Stimulator, Muscle, Powered, For Muscle Conditioning 1System, X-Ray, Fluoroscopic, Image-Intensified 1Vibrator, Therapeutic 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203710	Storz Medical MAGNETOLITH Muscle Stimulator	2021-05-03
US	K202112	Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece	2021-02-21
US	K173692	D-Actor 200 Vibration Massage System	2018-04-13
BR	80047309239	D-ACTOR® 200	Class II
BR	80047309240	D-ACTOR® 100	Class II
CA	11619	STORZ X-RAY IMAGING SYSTEM	Class III
CA	16896	MODULITH SL-20	Class III
CA	97307	HIRIS RF43FL	Class II