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SHOCKWAVE MEDICAL, INC.

USA · Santa Clara

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

4listed device types

Class I 0Class II 3Class III 1

plus 14 registration records and 13 510(k), 24 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class IV 1

7 including historic records

TWTaiwanTFDA

9valid device licences

Class II 6Class III 3

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

7active ARTG entries

Class III 2IIb 5

HKHong KongMDACS

4valid listings

Class II 1Class IV 3

ILIsraelAMAR

5registrations

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 States14 registration records, 13 510(k), 24 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SHOCKWAVE MEDICAL, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262201	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter	2026-07-27
US	K243757	Shockwave CS Guide Catheter	2025-05-02
US	K242213	Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter	2024-09-27
BR	81504799245	Cateter de Litotrícia Intravascular (IVL) Periférica Shockwave E8	Class II
BR	81504799062	Cateter para litotrícia intravascular (LIV) periférica	Class II
CA	108261	SHOCKWAVE CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM	Class IV

SHOCKWAVE MEDICAL, 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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