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INTEGRATION DIAGNOSTICS SWEDEN AB.

Sweden · Goteborg Vastra Gotaland

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

0active device licences

1 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 2IIa 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2a 3

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 States1 registration records, 2 510(k), 0 PMA, 7 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: INTEGRATION DIAGNOSTICS SWEDEN AB · INTEGRATION DIAGNOSTICS AB · INTEGRATION DIAGNOSTICS SWEDEN AB.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K033689	OSSTELL MENTOR RFA	2004-02-26
US	K003714	OSSTELL RESONANCE FREQUENCY ANALYZER	2001-08-09
BR	81034250014	Dispositivo de avaliação da estabilidade de implantes dentários	Class I

INTEGRATION DIAGNOSTICS SWEDEN AB.

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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