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Innovacon, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

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

18active device licences

Class II 12Class III 6

37 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 2 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

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, 3 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 1 excluded

Canada18 confirmed, 0 excluded

Manufacturer names merged into this page: INNOVACON, INC. · INNOVACON, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K063673	INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE	2007-03-05
US	K061718	INNOVACON SPECTRUM II TEST CARD	2006-11-13
US	K062361	INNOVACON HCG UKTRA TEST DEVICE	2006-10-23
BR	10071770911	SureStep One Step AMP 500 One Step Amphetamine Test Strip (Urine)	Class II
BR	10071770904	SureStep One Step Benzoadiazepines Test Strip (Urine)	Class II
BR	10071770905	SureStep Multi-Drug One Step Multi-Line Screen Test Panel with Integra	Class II
CA	88931	ALERE INSTRUMENTED TEST SYSTEM WITH DXLINK TECHNOLOGY	Class II
CA	64235	INNOVACON MIDSTREAM HOME PREGNANCY TEST	Class II
CA	68226	LH ONE STEP OVULATION TEST STRIP (URINE)	Class II

Innovacon, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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