TUV NORD Polska Sp. z o.o.

TUV NORD Polska Sp. z o.o
ul. Mickiewicza 29
40-085 Katowice
Country : Poland
Phone : +48 32 7864646
Fax : +48 32 7864601
Email : biuro@tuv-nord.pl
Notified Body number : 2274
Website : TUV NORD Polska Sp. z o.o

Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0102: Non-active devices for injection, infusion, transfusion and dialysis
MD 0103: Non-active orthopedic and rehabilitation devices
MD 0104: Non-active Devices with measuring function
MD 0106: Non-active instruments
MD 0107: Contraceptive medical devices
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0301: Bandages and wound dressings
MD 0303: Other material for wound care
MD 1101: Devices for exracorporeal circulation, infusion and hemopheresis
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1103: Devices for stimulation or inhibition
MD 1104: Active surgical devices
MD 1106: Active dental devices
MD 1107: Active devices for disinfection and sterilisation
MD 1108: Active rehabilitation Devices and active prostheses
MD 1109: Active devices for patient positioning and transport
MD 1111: Software
MD 1201: Imaging devices utilising ionizing radiation
MD 1202: Imaging devices utilising non-ionizing radiation
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1302: Monitoring devices of vital physiological parameters
MD 1401: Devices utilising ionizing radiation
MD 1402: Devices utilising non-ionizing radiation

Horizontal Technical Competence
MDS 7001: Medical devices incorporating medicinal substances
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition

ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance