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Please get in touch with us via our
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Personal contact is important for us!
Please get in touch with us via our
Online Contact Form.
MDA 0203
Active non-implantable devices for monitoring vital physiological parameters (no restrictions).
MDA 0204
Other active non-implantable monitoring and/or diagnostic devices (excluding audiometers, tonometers, and fundus cameras).
MDA 0302
Active non-implantable devices using non-ionizing radiation (excluding pain therapy lasers, patient phototherapy devices, non-invasive echo treatment robots for varicose veins, and ophthalmic refractive surgery lasers).
MDA 0305
Active non-implantable devices for stimulation or inhibition (excluding electroacupuncture devices).
MDA 0306
Active non-implantable devices for extracorporeal circulation, substance administration/removal, and blood separation (excluding blood pumps for heart-lung machines).
MDA 0307
Active non-implantable respiratory devices (excluding hyperbaric oxygen chambers)
MDA 0312
Other active non-implantable surgical devices (excluding pressure regulators for surgical sealant or hemostatic sprays).
MDA 0315
Software (excluding radiotherapy planning systems).
MDA 0318
Other active non-implantable devices (no restrictions).
MDN 1101
Passive cardiovascular, vascular, and neurovascular implants (no restrictions).
MDN 1102
Passive bone and orthopedic implants (excluding artificial intervertebral discs, joint replacement prostheses such as knee and hip implants, intra-articular hyaluronic acid implants, and synthetic ligament reconstruction products).
MDN 1104
Passive soft tissue and other implants (limited to hernia meshes, urethral stent implants, sutures, collagen soft tissue implants, adhesion-prevention implants, and collagen-based hemostatic or sealing agents).
MDN 1201
Passive non-implantable devices for anesthesia, emergency care, and intensive care (no restrictions).
MDN 1202
Passive non-implantable devices for substance administration, guidance, and removal (including dialysis equipment, but excluding dialysis filters and dialysis fluids).
MDN 1203
Passive non-implantable guiding catheters, balloon catheters, guidewires, introducers, filters, and related tools (excluding thrombectomy catheters).
MDN 1208
Passive non-implantable instruments (excluding dental instruments).
MDN 1211
Passive non-implantable devices for disinfection, cleaning, and rinsing (limited to disinfectant solutions and wipes for medical devices).
IVR 0301
Devices for cancer screening, diagnosis, staging, or monitoring
IVR 0302
Other devices for cancer and non-malignant tumor markers
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0401
Devices for screening/confirmation of congenital or hereditary diseases
IVR 0402
Devices for predicting risk or prognosis of hereditary diseases
IVR 0403
Other devices for human genetic testing
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0501
Devices for prenatal screening of pregnant women to determine immunity to transmissible agents
IVR 0502
Devices for detecting the presence or exposure of transmissible agents in blood or blood components, to assess suitability for transfusion or similar use
IVR 0503
Devices for detecting infectious agents (including sexually transmitted agents)
IVR 0504
Devices for determining infection load, disease state, immune status, or stage of infectious disease
IVR 0505
Devices for culturing, isolating, identifying, and handling infectious agents
IVR 0506
Other devices for determining infection/immune status markers
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0601
Devices for screening/confirmation of specific diseases or injuries
IVR 0602
Devices for screening, measuring, or monitoring physiological markers of specific diseases
IVR 0603
Devices for screening, confirmation, measurement, or monitoring of allergies and intolerances
IVR 0604
Other devices for specific diseases
IVR 0605
Devices for monitoring drug, substance, or biological component levels
IVR 0606
Devices for staging of non-infectious diseases
IVR 0607
Devices for pregnancy detection or fertility testing
IVR 0608
Devices for screening, measuring, or monitoring physiological markers
IVR 0609
Other devices for defining or monitoring physiological states and therapeutic measures
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0701
IVR 0702
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVR 0801
Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
IVR 0802
Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
IVR 0803
Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
Applicable Annexes: Annex IX(I), Annex IX(II), Annex XI
IVD 4001
In vitro diagnostic devices which require knowledge regarding bacteriology
IVD 4002
In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry
IVD 4004
In vitro diagnostic devices which require knowledge regarding genetics
IVD 4005
In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders
IVD 4007
In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology
IVR 0801
Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
IVR 0803
Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
IVR 0801
Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
IVR 0802
Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
IVR 0803
Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746