NOUVAG AG

Switzerland · Goldach

✓ 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

16listed device types

Class I 9Class II 7Class III 0

plus 14 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 10Class II 7

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

18active device licences

Class II 18

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

26active ARTG entries

Class I 8IIa 17IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 6Class 2b 5

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 States14 registration records, 11 510(k), 0 PMA

Brazil17 confirmed, 0 excluded

Canada18 confirmed, 0 excluded

Manufacturer names merged into this page: NOUVAG AG

FDA 510(k) clearances by year

11996

11999

12000

12001

12003

32004

12007

12008

12009

FDA listed device types

showing 8 of 16

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Catheter And Tip, Suction 1Pump, Infusion 1Motor, Drill, Electric 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Drill, Bone, Powered 1Pump, Portable, Aspiration (Manual Or Powered) 1Motor, Surgical Instrument, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K080365	MORCE POWER PLUS AND VARIOCARVE MORCELLATOR	2009-06-29
US	K081191	TCM ENDO 20	2008-08-07
US	K071588	DISPENSER DP 20	2007-11-26
BR	10355879040	HIGHSURG	Class II
BR	10355870403	1924nou - Peça de mão Trépano	Class I
BR	10355879045	TUBO DE SUCÇÃO COM FUNIL	Class II
CA	73908	MICRO MOTOR SYSTEMS	Class II
CA	74264	TCM ENDO V ROOT CANAL MEASUREMENT AND TREATMENT SYSTEM	Class II
CA	74265	TCM ENDO III ENDODONTIC MOTOR SYSTEM	Class II

NOUVAG 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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