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Cooper Medical Corp.

Costa Rica · La Garita Alajuela

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 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

11listed device types

Class I 1Class II 10Class III 0

plus 67 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States67 registration records, 31 510(k), 0 PMA, 7 excluded

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: COOPER MEDICAL, SRL

Same-named companies — This database also contains companies with near-identical names: Cooper Biomedical, Inc., Cooper Medical Devices Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11979

41980

21981

11982

11983

81984

101985

21986

21987

FDA listed device types

showing 8 of 11

Needle, Assisted Reproduction 1Catheter, Assisted Reproduction 1Cannula, Intrauterine Insemination 1Microtools, Assisted Reproduction (Pipettes) 1Media, Reproductive 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Semen Analysis Device 1Pessary, Vaginal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K864512	IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO	1987-02-13
US	K863868	IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT	1987-02-13
US	K863301	DEMAND TOTAL PROTEIN	1986-09-26

Cooper Medical Corp.

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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