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Vitalograph , Ltd.

USA · Lenexa

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore — 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

22510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

10 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

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, 22 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: VITALOGRAPH INC. · Vitalograph Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253293	VitaloJAK Clinic (Model 7100)	2025-12-03
US	K000599	VITALOGRAPH BASE STATION	2000-09-08
US	K991412	VITALOGRAPH MICRO	2000-02-04
SA	ME0000002008SFDAA00001	Bacterial Viral Filters	—
CA	7725	COMPACT SPIROMETER	Class II
CA	7732	DATA STORAGE SPIROMETER	Class II

Vitalograph , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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