BEUDAMED
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    OPKO HEALTH SPAIN S.L.U.

    Manufacturer
    🇪🇸 Spain·9 Basic UDI-DIs·9 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

    Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO

    FDA Enforcement
    Class II ·Completed·LEASEIR TECHNOLOGIES SLU·January 28, 2026

    Iberhospitex, S.A.

    Manufacturer
    🇪🇸 Spain·49 Basic UDI-DIs·54 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    i+Med S.Coop.

    Manufacturer
    🇪🇸 Spain·21 Basic UDI-DIs·26 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, BSI Group The Netherlands B.V., CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    TEQUIR S.L.

    Manufacturer
    🇪🇸 Spain·71 Basic UDI-DIs·71 Devices·Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., and Kiwa Belgelendirme Hizmetleri A.Ş.

    VEC MEDICAL SPAIN, S.L.

    Manufacturer
    🇪🇸 Spain·3 Basic UDI-DIs·5 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, and CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    S.E. Carburos Metálicos, S.A.

    Manufacturer
    🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS

    ANACONDA BIOMED, S.L.

    Manufacturer
    🇪🇸 Spain·1 Basic UDI-DI·1 Device·DEKRA Certification B.V. and DEKRA Certification B.V.

    Instituto de Investigación Biotecnológica, Farmacéutica y Medicamentos Huérfanos, S.L.

    Manufacturer
    🇪🇸 Spain·1 Basic UDI-DI·1 Device·Kiwa Belgelendirme Hizmetleri A.Ş. and Kiwa Belgelendirme Hizmetleri A.Ş.

    Biosurgical S.L

    Manufacturer
    🇪🇸 Spain·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and SGS Belgium NV

    histocell

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·2 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS and CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    Medical Cables S.L.

    Manufacturer
    🇪🇸 Spain·331 Basic UDI-DIs·331 Devices·SGS Belgium NV and SGS Belgium NV

    PROMECHI, S.L.

    Manufacturer
    🇪🇸 Spain·15 Basic UDI-DIs·15 Devices·SGS Belgium NV and SGS Belgium NV

    VIMAP TECHNOLOGIES, S.L.U

    Manufacturer
    🇪🇸 Spain·18 Basic UDI-DIs·18 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS and CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    ABANZA TECNOMED, S.L.

    Manufacturer
    🇪🇸 Spain·28 Basic UDI-DIs·30 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    PEGISDAN, S.R.L.U.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·2 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS and CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    MESSER IBÉRICA DE GASES SAU

    Manufacturer
    🇪🇸 Spain·17 Basic UDI-DIs·17 Devices·TÜV Rheinland LGA Products GmbH and CERTIQUALITY S.r.l.

    Tuylek, s.l.

    Manufacturer
    🇪🇸 Spain·4 Basic UDI-DIs·4 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS and CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

    Skin Tech Pharma Group, SL

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·2 Devices·Szutest Uygunluk Değerlendirme A.Ş.

    PROTEOS BIOTECH SL

    Manufacturer
    🇪🇸 Spain·1 Basic UDI-DI·1 Device·Kiwa Belgelendirme Hizmetleri A.Ş.