Planmed Oy

Finland · Helsinki

✓ 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

4listed device types

Class I 0Class II 4Class III 0

plus 3 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class III 6

10 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 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 States3 registration records, 20 510(k), 0 PMA

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Planmed Oy · PLANMED OY

FDA 510(k) clearances by year

11992

11994

11995

21997

11998

11999

12001

12002

12003

12004

12012

12013

12015

12017

12018

12020

22022

12025

FDA listed device types

System, X-Ray, Tomography, Computed 1Full Field Digital, System, X-Ray, Mammographic 1X-Ray, Computed Tomography, Cone-Beam 1X-Ray, Tomography, Computed, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250318	Planmed XFI	2025-09-26
US	K211720	Planmed Clarity 2D, Planmed Clarify S	2022-07-18
US	K213278	Planmed Verity	2022-04-28
CA	67061	SOPHIE MAMMOGRAPHY X-RAY SYSTEM	Class III
CA	67514	SOPHIE MOBILE	Class III
CA	67513	SOPHIE CLASSIC MOBILE	Class III

Planmed Oy

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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