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Cook Urological, Inc.

USA · Spencer

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

104510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 104 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

7active device licences

Class II 4Class IV 3

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

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 States0 registration records, 104 510(k), 0 PMA, 7 excluded

Brazil1 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: COOK UROLOGICAL INC. · COOK UROLOGICAL

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102141	COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)	2011-05-06
US	K091767	3 WAY SILICONE FOLEY BALLOON CATHETER	2009-10-09
US	K082939	COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400	2009-09-03
BR	10212990269	COLETOR DE DRENAGEM COOK	Class II
CA	7607	CATHETER RETENTION SYSTEMS	Class II
CA	12584	COOK TISSUE MORCELLATOR	Class II
CA	15826	SURGISIS SOFT TISSUE GRAFT - PORCINE	Class IV

Cook Urological, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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