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Certified Management Systems

  • Management Systems

    EN ISO 13485 i MDR Ann. IX, Chapt I

  • Certificate Holder

    Meden-Inmed Sp. z o.o.

  • Test Mark Number

    0000073249

The certificate holder's Management System corresponds to standard ISO 13485:2016.

Certificate scopes

  • EN ISO 13485

    Design, production, sales and servicing of medical devices for hydrotherapy, physical therapy, physical rehabilitation, tables for rehabilitation treatments, massage tables, traction tables, tables for verticalization, hoists for the transfer of disabled persons, devices for heating treatment masses, treatment furniture, medical supply units (panel system with gas installations), ophthalmic boards.
    Sales and servicing of ESWL and ESWT cameras, devices for EEG and EMG, magnetic stimulators, devices for urodynamics, medical lasers, endoscopes, implants and implantable materials, integrated operating rooms, surgical lights, operating tables, devices for electrotherapy, physiotherapy equipment, neuro-rehabilitation devices, devices for cardiology and cardiac rehabilitation, lasers for rehabilitation, equipment for Neurac therapy, kinesitherapy devices, devices for diagnosis and movement analysis, patient care systems, cryogenic and hyperbaric chambers.

  • MDR Ann. IX, Chapt I

    Class IIa:
    Z120614 - INFRARED/ULTRAVIOLET LIGHTS
    Z120690 - VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS
    Z120618 - FULL BODY WHIRLPOOL BATHS

    Class IIb:
    Z120309 - MEDICAL/MEDICINAL GAS SYSTEMS AND RELATIVE
    ACCESSORIES

Certificates for these Management Systems

Information

Contact to the certificate holder

Meden-Inmed Sp. z o.o.

ul. Wenedów 2
75-847 Koszalin
Polska