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Bts S.P.A.

Italy · Padova

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, South Korea, Israel, Russia — 6 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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, 2 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia3 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BTS S.P.A · BTS S.p.A.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K161716	TEETHAN 2.0	2016-12-21
US	K131660	SMART (SMART-D, SMART-DX)	2014-04-17
BR	81322780004	Plataforma de Força BTS P-6000	Class I
BR	81322789001	Sensores de Análise Funcional de Movimentos	Class II
BR	81322789002	Sistema de Aquisição de Imagens e Eletromiografia (EMG)	Class II
SA	ME0000002547SFDAA00004	Nirvana	—
SA	ME0000002547SFDAA00003	BTS G-Walk	—

Bts S.P.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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