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THOMMEN MEDICAL, AG

Switzerland · Grenchen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Russia — 5 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 2Class II 2Class III 0

plus 31 registration records and 26 510(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

9active device licences

Class II 1Class III 8

40 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 2Class III 3

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 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 States31 registration records, 26 510(k), 0 PMA

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: THOMMEN MEDICAL, AG · THOMMEN MEDICAL AG

FDA 510(k) clearances by year

12002

32003

12004

22005

12006

62007

12008

32009

22010

22011

12012

22016

12017

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1Handle, Instrument, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171795	Thommen Implant System	2017-09-29
US	K160244	VARIOunite	2016-06-02
US	K151984	Thommen Milling Abutment for CAD/CAM	2016-03-10
CA	77140	SPI ABUTMENT FOR TEMPORARY RESTORATIONS INCL. FABRICATION SCREW	Class III
CA	77141	SPI TITANIUM COPING, BAR	Class III
CA	77142	SPI GOLD COPING, BAR	Class III

THOMMEN MEDICAL, AG

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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