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ATOS MEDICAL AB

Sweden · Horby

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, 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

17listed device types

Class I 14Class II 3Class III 0

plus 25 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

56registered devices

Class I 37Class II 19

60 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 2Class III 4

33 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

37active ARTG entries

Class I 24IIa 6IIb 7

HKHong KongMDACS

9valid listings

Class II 1Class III 8

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

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 States25 registration records, 15 510(k), 0 PMA

Brazil56 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: ATOS MEDICAL AB

FDA 510(k) clearances by year

11990

11993

21994

11995

11997

22002

12004

12008

12009

12010

12013

12014

12016

FDA listed device types

showing 8 of 17

Prosthesis, Laryngeal (Taub) 1Tube Tracheostomy And Tube Cuff 1Tracheostomy Kit 1Exerciser, Non-Measuring 1Instrument, Ent Manual Surgical 1Tube, Laryngectomy 1Larynx, Artificial (Battery-Powered) 1Prosthesis, Adhesive, External 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151404	ProTrach Dualcare	2016-02-12
US	K141380	PROVOX FREEHANDS FLEXIVOICE	2014-09-26
US	K131947	PROVOX VEGA PUNCTURE SET	2013-10-18
BR	80073250046	SISTEMA PARA REABILITAÇÃO DA MODALIDADE MANDIBULAR THERABITE	Class I
BR	10430319086	Dilatador Provox Reutilizável	Class II
BR	10430319087	Dilatador Provox Uso único	Class II
CA	5162	PROVOX STOMA FILTER SYSTEM	Class II
CA	13674	PROVOX VOICE PROSTHESIS SYSTEM	Class III
CA	13908	PROVOX II VOICE PROSTHESIS SYSTEM	Class III