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Soredex Palodex Group OY

Finland · Tuusula

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel, Russia — 7 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

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(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

12active device licences

Class II 10Class III 2

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 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 States0 registration records, 9 510(k), 0 PMA, 3 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: PALODEX GROUP OY ALSO TRADING AS SOREDEX

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110839	SCANORA 3D	2011-06-30
US	K073350	SCANORA 3D	2007-12-19
US	K070304	DIGORA PCT/DIGIPOD	2007-03-27
CA	30683	CRANEX	Class II
CA	30684	SCANORA	Class II
CA	30685	CRANEX TOME	Class II

Soredex Palodex Group OY

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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