EU → US Device Access

BTL Industries Limited

GB-MF-000034894 · United Kingdom · Stevenage

BTL Industries Limited is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa35
Class IIb30

Most frequent device types declared: Applicator Easy, 713/1, BTL-6000 RSWT Elite, 713/2, Applicator Magnum.

Among these devices, 39 are declared active.

Authorised representative in the Union: IT-AR-000020508.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryBTL Industries JSC (BG) · FDA 3035374386
Devices in EUDAMED65
Country of registrationUnited Kingdom
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
HZ 2036797-1supplemented2028-02-02
051/MDRsupplemented2027-10-06

Other manufacturers in United Kingdom

All United Kingdom manufacturers →