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CLINIQA CORPORATION

USA · San Marcos

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 4 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

57listed device types

Class I 27Class II 30Class III 0

plus 104 registration records and 36 510(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

2 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States104 registration records, 36 510(k), 0 PMA

Manufacturer names merged into this page: CLINIQA CORPORATION

FDA 510(k) clearances by year

12001

82002

102003

62004

12005

32006

12007

22008

22009

12012

12013

FDA listed device types

showing 8 of 57

Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Calibrator, Primary 1Mercuric Thiocyanate, Colorimetry, Chloride 1Electrode, Ion-Specific, Chloride 1System, Test, C-Reactive Protein 1Catalytic Methods, Amylase 1Haptoglobin, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K120900	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2	2013-05-31
US	K121237	BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE	2012-05-18
US	K083554	CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3	2009-04-21

CLINIQA CORPORATION

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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