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BTS SPA

Italy · Garbagnate Milanese
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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 1Class II 3Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
6 including historic records
TWTaiwanTFDA
pendingnot queried
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 States4 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: BTS SPA · BTS SpA

Company information

Country
Italy
City
Garbagnate Milanese

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 listed device types

Device, Biofeedback 1Device, Muscle Monitoring 1Interactive Rehabilitation Exercise Devices 1Platform, Force-Measuring 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000006138SFDAA00077P6000—
CA89887OEP SYSTEM - OPTOELECTRONIC PLETHYSMOGRAPHY SYSTEMClass II
CA89888SMART-D MOTION ANALYSIS SYSTEMClass II

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