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Vitalograph (Ireland) , Ltd.

Ireland · Ennis

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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 3Class II 8Class III 0

plus 24 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

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

8active device licences

Class II 8

22 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 3IIa 4Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2b 1

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 States24 registration records, 12 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: VITALOGRAPH IRELAND LTD. · VITALOGRAPH (IRELAND) LTD · VITALOGRAPH (IRELAND) LTD.

FDA 510(k) clearances by year

12008

12010

12011

12014

22015

12016

22020

22022

12023

FDA listed device types

showing 8 of 11

Clip, Nose 1Calibrator, Volume, Gas 1Mouthpiece, Breathing 1Spirometer, Therapeutic (Incentive) 1Meter, Peak Flow, Spirometry 1Spirometer, Diagnostic 1Calculator, Predicted Values, Pulmonary Function 1Transmitters And Receivers, Electrocardiograph, Telephone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223818	Model 9160 VitaloQUB	2023-05-25
US	K221030	Model 9100 PFT/DICO	2022-07-15
US	K212938	Vitalograph Model 6000 Alpha	2022-01-26
BR	82531179001	ESPIRÔMETRO VITALOGRAPH	Class II
BR	82531170005	Nose Clips with Foam Pads Vitalograph	Class I
BR	82531170006	Cilindro volumétrico de 3 L de calibração	Class I
SA	ME0000005243SFDAA00001	SafeTway Mouthpieces	—
CA	66441	2110 ELECTRONIC PEF/FEV DIARY	Class II
CA	66442	2120 SPIROMETER	Class II
CA	66443	ALPHA SPIROMETER	Class II

Vitalograph (Ireland) , Ltd.

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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