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It-V Medizintechnik, GmbH

Austria · Stamford

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 6

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

SASaudi ArabiaSFDA

15registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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, 1 510(k), 0 PMA, 10 excluded

Brazil6 confirmed, 2 excluded

Saudi Arabia15 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: IT-V Medizintechnik GmbH · IT-V MEDIZINTECHNIK GMBH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081218	BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST	2008-07-21
BR	80569320023	BreastStep	Class I
BR	80569320021	WINGSTEP	Class I
BR	80569320036	CT STEP Overlay	Class I
SA	ME0000001937SFDAA00022	CT STEP Basic Modul	—
SA	ME0000001937SFDAA00025	TBI Adapter CS	—

It-V Medizintechnik, GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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