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Home›France›Satelec - Acteon Group

Satelec - Acteon Group

France · Merignac Gironde
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 4 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
15listed device types
Class I 6Class II 8Class III 0unclassified 1
plus 42 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 1Class II 5
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
17active device licences
Class II 16Class III 1
49 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States42 registration records, 12 510(k), 0 PMA, 1 excluded
Brazil6 confirmed, 1 excluded
Canada17 confirmed, 0 excluded
Manufacturer names merged into this page: SATELEC-ACTEON GROUP · SATELEC A COMPANY OF ACTEON GROUP · SATELEC ACTEON INC.
Same-named companies — This database also contains companies with near-identical names: SATELEC A COMPANY OF ACTEON GROUP. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Merignac Gironde

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

22007
32012 · K113430
12013 · K131997
42014 · K131906
12018 · K172137
12024 · K233922

FDA listed device types

showing 8 of 15
Controller, Foot, Handpiece And Cord 1Handpiece, Direct Drive, Ac-Powered 1Handpiece, Air-Powered, Dental 1Unit, Operative Dental 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Otoscope 1Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Activator, Ultraviolet, For Polymerization 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG2024-03-11
USK172137PIEZOTOME CUBE2018-05-03
USK131906SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE2014-04-11
BR80840260013ULTRASSOM ODONTOLÓGICOClass II
BR80840260008NEWTRON P5Class II
BR80840269005newtron boosterClass II
CA20395NEOSONO ULTIMA EZ APEX LOCATOR/PULP TESTERClass II
CA20393TEAM UPClass II
CA20394SUPRASSON P5 BOOSTERClass II

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