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VectraCor, Inc.

USA · Totowa

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Australia — 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

13listed device types

Class I 3Class II 9Class III 0unclassified 1

plus 15 registration records and 3 510(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

16active device licences

Class II 13Class III 3

20 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 4IIb 2

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 States15 registration records, 3 510(k), 0 PMA

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: VectraCor, Inc. · VECTRACOR, INC.

FDA 510(k) clearances by year

12011 · K102378

12015 · K140852

12018 · K173952

FDA listed device types

showing 8 of 13

Clip, Nose 1Calibrator, Volume, Gas 1Mouthpiece, Breathing 1System, Network And Communication, Physiological Monitors 1Computer, Diagnostic, Programmable 1Electrocardiograph, Ambulatory (Without Analysis) 1Electrode, Electrocardiograph 1Spirometer, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173952	Universal SmartECG	2018-08-28
US	K140852	VECTRAPLEX CMS	2015-01-30
US	K102378	VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI	2011-11-02
CA	30016	SENSAIRE HANDHELD DIAGNOSTIC SPIROMETER	Class II
CA	30018	ECG ELECTRODES (TAB AND SNAP TYPE)	Class II
CA	32394	SPIROXCARD, DIAGNOSTIC SPIROMETER AND PULSE OXIMETER	Class III

VectraCor, Inc.

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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