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Gyrus ACMI, Inc.

USA · Westborough

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

160listed device types

Class I 47Class II 108Class III 2unclassified 3

plus 542 registration records and 44 510(k), 38 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

43active device licences

Class II 40Class III 3

225 including historic records

TWTaiwanTFDA

18valid device licences

Class II 18

SGSingaporeHSA SMDR

34device registrations

CLASS B 16CLASS C 18

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

83active ARTG entries

Class I 29IIa 29IIb 15Class Im (measuring) 1Class Is (sterile) 9

HKHong KongMDACS

5valid listings

Class II 1Class III 4

ILIsraelAMAR

17registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States542 registration records, 44 510(k), 38 PMA, 4 excluded

Brazil8 confirmed, 2 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada43 confirmed, 1 excluded

Manufacturer names merged into this page: Gyrus ACMI, Inc. · GYRUS ACMI, INC. · GYRUS ACMI, INC · GYRUS ACMI,INC · GYRUS ACMI INC.

FDA 510(k) clearances by year

12007

52008

42009

42010

32011

42012

12013

32014

32015

52016

22017

22018

12021

22022

22023

12024

12026

FDA listed device types

showing 8 of 160

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Endoscopic Access Overtube, Gastroenterology-Urology 1Lithotriptor, Biliary Mechanical 1Display, Cathode-Ray Tube, Medical 1Resectoscope, Working Element 1Colposcope (And Colpomicroscope), Exempt 1Syringe, Balloon Inflation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252487	POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)	2026-03-02
US	K233275	RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)	2024-03-25
US	K231327	POWERSEAL Sealer and Divider	2023-10-25
BR	80081350282	ELETRODO	Class II
BR	80081350004	INSTRUMENTAL SNAP-IN SNAP-OUT PARA ENDOSCOPIA CIRCON ACMI	Class I
BR	80081350075	RESECTOSCOPIO CIRCON ACMI	Class II
SA	ME0000002534SFDAA00001	LITHOTRIPSY WRENCH ShockPulse-SE	—
SA	ME0000002534SFDAA00076	EasySuite 4K Video Manager	—
CA	6697	BOVIE CHUCK HANDLE, WITH BLADE	Class II
CA	15643	STORAGE-STERILIZATION AND DISINFECTION SYSTEMS	Class II
CA	15649	CIRCON WIDEVIEW ARTHROSCOPES	Class II