HomeFranceNovatech SA

Novatech SA

France · La Ciotat Cedex
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 7 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(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
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 2CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 4IIa 2IIb 2
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 States0 registration records, 5 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 3 excluded
Manufacturer names merged into this page: NOVATECH SA

Company information

Country
France
City
La Ciotat Cedex

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11997 · K971509
12016 · K151832
12017 · K170030
12024 · K243126
12025 · K242324

Registration details (sample)

MarketIdentifierNameClass / date
USK242324DUTAU-NOVATECH®2025-02-06
USK243126TRACHEOBRONXANE™ DUMON®2024-10-29
USK170030NOVATECH TALCAIR2017-03-13

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