INSTYTUT TECHNOLOGII ELEKTRONOWEJ ODDZIAŁ PREDOM
ul. Krakowiakow 53
02-255 WARSZAWA
Country : Poland
Phone : +48 22 846 54 31
Fax : +48 22 846 19 05
Email : obr@predom.com.pl
Notified Body number : 1451
Website : INSTYTUT TECHNOLOGII ELEKTRONOWEJ ODDZIAŁ PREDOM
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 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1401: Devices utilising ionizing radiation
MD 1403: Devices for hyperthermia / hypothermia
Horizontal Technical Competence
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
ANNEXES
MDD ANNEX IV: EC Verification
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance