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E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

Switzerland · Nyon

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore — 5 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

16listed device types

Class I 6Class II 9Class III 1

plus 98 registration records and 48 510(k), 2 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 2Class II 16

21 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

14active device licences

Class II 12Class III 2

45 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

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 States98 registration records, 48 510(k), 2 PMA, 44 excluded

Brazil18 confirmed, 3 excluded

Saudi Arabia3 confirmed, 3 excluded

Canada14 confirmed, 10 excluded

Manufacturer names merged into this page: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. · ELECTRO MEDICAL SYSTEMS, L.L.C. · E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. · E.M.S ELECTRO MEDICAL SYSTEMS S.A · EMS ELECTRO MEDICAL SYSTEMS SA · E.M.S. ELECTRO MEDICAL SYSTEM S.A.

Same-named companies — This database also contains companies with near-identical names: E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd., Electro Medical Systems, Inc., ELECTRO MEDICAL SYSTEMS, L.L.C.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22000

12001

22002

12003

12005

32007

22009

22010

12011

32013

22014

12015

12016

22017

42018

32019

12022

12023

12025

12026

FDA listed device types

showing 8 of 16

Lithotriptor, Electro-Hydraulic 1Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers 1Scaler, Ultrasonic 1Airbrush 1Scaler, Rotary 1Evacuator, Gastro-Urology 1Lithotriptor, Ultrasonic 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253254	GBT Machine Airflow Prophylaxis Master	2026-01-28
US	K243279	DOLORCLAST Focused Shock Waves	2025-08-13
US	K230893	Swiss LthoClast Trilogy	2023-10-23
BR	80102519310	SWISS DOLORCLAST® smart 20	Class II
BR	80102519348	Piezon® No Pain Built-in Kit	Class II
BR	80102519380	GBT Machine AIRFLOW® Prophylaxis Master	Class II
SA	ME0000001888SFDAA00024	Swiss LithoCart	—
SA	ME0000007100SFDAA00009	Air- Flow -Classic Lemon Powder	—
CA	13911	SWISS LITHOCLAST LITHOTRIPTOR SYSTEM	Class III
CA	20952	KERMIT	Class II
CA	21740	SWISS ORTHOCLAST	Class II

E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

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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