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Disior, Ltd.

Finland · Helsinki Uusimaa

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Singapore, Israel — 3 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

3listed device types

Class I 0Class II 3Class III 0

plus 6 registration records and 6 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States6 registration records, 6 510(k), 0 PMA

Manufacturer names merged into this page: DISIOR OY

FDA 510(k) clearances by year

12021 · K203290

12023 · K223757

22024 · K240736

12025 · K250023

12026 · K253764

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Software For Diagnosis/Treatment 1

Market	Identifier	Name	Class / date
US	K253764	ENOS Software Guided External Fixation System	2026-02-26
US	K250023	SMART PCFD	2025-09-29
US	K240736	SMART Bun-Yo-Matic X-Ray	2024-07-02

Disior, 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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