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BTL Industries JSC

Bulgaria · Plovdiv

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 5 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

13listed device types

Class I 2Class II 11Class III 0

plus 29 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

27registered devices

Class I 1Class II 26

30 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

52 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States29 registration records, 45 510(k), 0 PMA, 2 excluded

Brazil27 confirmed, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: BTL Industries JSC · BTL INDUSTRIES LIMITED · BTL INDUSTRIES LTD. · BTL INDUSTRIES JSC · BTL Industries Limited

FDA 510(k) clearances by year

12009

12010

12012

12013

12014

62015

42016

22017

42018

32019

12021

32022

52023

52024

42025

32026

FDA listed device types

showing 8 of 13

Vibrator, Therapeutic 1Table, Powered 1Electrosurgical, Cutting & Coagulation & Accessories 1Lamp, Infrared, Therapeutic Heating 1Stimulator, Muscle, Powered 1Transcranial Magnetic Stimulator 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Stimulator, Electrical, Non-Implantable, For Incontinence 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252963	BTL-899TT	2026-06-12
US	K253750	BTL-785NEH	2026-03-17
US	K252561	BTL-754FF	2026-02-18
BR	83234539001	BTL SUPER INDUCTIVE SYSTEM DUO	Class II
BR	80991699026	Eletrocardiógrafo	Class II
BR	80991699019	BTL-4000 SMART e BTL-4000 PREMIUM	Class II
SA	ME0000008843SFDAA00001	BTL-1100	—
SA	ME0000003542SFDAA00001	BTL-1300	—
CA	101996	BTL-5000 SERIES (MAGNET)	Class II
CA	101997	BTL-4000 (SMART/PREMIUM)	Class II
CA	80112	BTL-MAGNET SERIES MAGNETIC FIELD THERAPY UNITS	Class II

BTL Industries JSC

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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