Home›USA›COOPER SURGICAL, INC.

COOPER SURGICAL, INC.

USA · Huntington

✓ Record-verifiedregistrations found in 9 markets

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

7510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 7Class II 6

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

43active device licences

Class II 28Class III 15

115 including historic records

TWTaiwanTFDA

6valid device licences

Class I 2Class II 4

SGSingaporeHSA SMDR

11device registrations

CLASS B 5CLASS D 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

15active ARTG entries

Class I 6IVD Class 1 1IVD Class 2 1IIa 2IIb 4Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 1

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 States0 registration records, 7 510(k), 0 PMA, 9 excluded

Brazil13 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada43 confirmed, 7 excluded

Manufacturer names merged into this page: COOPERSURGICAL, INC. · COOPER SURGICAL, INC. · CooperSurgical, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253698	Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes	2026-01-20
US	K091325	TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS	2009-06-29
US	K023382	COOPERSURGICAL MALLEABLE SYTLET	2002-12-20
BR	10234370042	Extrator Obstétrico a Vácuo Descartável, Marca Mityvac, Modelo Mystic	Class I
BR	10341350958	SISTEMA DE RETRAÇÃO SKW	Class II
BR	10318390049	SURE - PRO ULTRA WALLACE	Class II
SA	ME0000001058SFDAA00014	Wallach Accu-Shield. Reusable Clear Plate	—
CA	1645	FETAL CALC	Class III
CA	1669	FIRSTBEAT FETAL DOPPLER	Class III
CA	1670	CARDIOBEAT BLOOD FLOW DOPPLER	Class III

COOPER SURGICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies