HomeUnited Kingdom of Great Britain and Northern IrelandBTL INDUSTRIES LIMITED

BTL INDUSTRIES LIMITED

United Kingdom of Great Britain and Northern Ireland · Stevenage
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 30 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
0valid device licences
SGSingaporeHSA SMDR
21device registrations
CLASS B 17CLASS C 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
60active ARTG entries
Class I 14IIa 26IIb 20
HKHong KongMDACS
28valid listings
Class II 24Class III 4
ILIsraelAMAR
19registrations
RURussiaRoszdravnadzor
39active registrations
Class 1 1Class 2a 24Class 2b 14
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 States30 registration records, 45 510(k), 0 PMA, 1 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 FZE · BTL INDUSTRIES LIMITED · BTL INDUSTRIES LTD. · BTL INDUSTRIES JSC · BTL Industries Limited

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Stevenage

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.

Business registration

Company number
04626905
Registration status
Active
Legal form
Private Limited Company
Incorporated
2003-01-02
Principal activity
82990 - Other business support service activities n.e.c.
Registered address
161 CLEVELAND WAY, STEVENAGE, SG1 6BU

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

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)

MarketIdentifierNameClass / date
USK252963BTL-899TT2026-06-12
USK253750BTL-785NEH2026-03-17
USK252561BTL-754FF2026-02-18
BR83234539001BTL SUPER INDUCTIVE SYSTEM DUOClass II
BR80991699026EletrocardiógrafoClass II
BR80991699019BTL-4000 SMART e BTL-4000 PREMIUMClass II
SAME0000008843SFDAA00001BTL-1100
SAME0000003542SFDAA00001BTL-1300
CA101996BTL-5000 SERIES (MAGNET)Class II
CA101997BTL-4000 (SMART/PREMIUM)Class II
CA80112BTL-MAGNET SERIES MAGNETIC FIELD THERAPY UNITSClass II

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