BTL Industries Limited

Certificate 051/MDR

Rev. 13Supplemented

Valid until: Oct 6, 2027

Certificate 051/MDR is a valid Quality management system issued to BTL Industries Limited and registered in EUDAMED. Valid until October 6, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 051/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051051/MDR13

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: Oct 6, 2027

Manufacturer

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

051/MDRSupplementedApr 16, 2026 → Oct 6, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa4Class IIb3

7 scopes

Dispositivi per terapia ad onde d’urto e relativi applicatori / Shockwave therapy devices and related applicators
Class IIa
Dispositivo ad alta frequenza, ultrasuoni ed elettrostimolazione e relativi accessori per trattamenti medici e non medici, come trattamenti per la pelle e la riduzione del grasso / High frequency, ultrasound and electrostimulation device and related accessories for medical treatment and non-medical treatments, such as skin treatment and fat reduction
Class IIb
Stimolatore neuromuscolare magnetico e a radiofrequenza e relativi accessori / Neuromuscular magnetic and radiofrequency stimulator and related accessories
Class IIa
Stimolatore neuromuscolare magnetico e relativi accessori / Neuromuscular magnetic stimulator and related accessories
Class IIa
Dispositivo a energia combinata di radiofrequenza e pressione focalizzata e relativi applicatori per trattamenti medici e non medici, come il trattamento della pelle e la riduzione del grasso / Radiofrequency and targeted pressure energy combined device and related applicators for medical and non-medical treatments, such as skin treatment and fat reduction
Class IIb
Dispositivo per la stimolazione magnetica transcranica ripetitiva e relativi accessori / Device for repetitive transcranial magnetic stimulation and related accessories
Class IIa
Dispositivo ad alta frequenza per trattamenti medici e non medici, come la riduzione del grasso, e relativi accessori / High frequency device for medical and non-medical treatments, such as fat reduction, and related accessories
Class IIb

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