Certificates

Management
Systems

EN ISO 13485

Compliance with
regulation

(EU) 2017/745

Certificate
Holder

Meden-Inmed Sp. z o.o.

Test Mark
Number

0000073249

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