BERLIN CERT PRÜF- UND ZERTIFIZIERSTELLE FÜR MEDIZINPRODUKTE GMBH AN DER TECHNISCHEN UNIVERSITÄT BERLIN
Dovestraße 6
10587 BERLIN
Country : Germany
Phone : +49:30:314 25111
Fax : +49:30:314 23719
Email : zert@berlincert.de
Notified Body number : 0633
Website : BERLIN CERT PRÜF- UND ZERTIFIZIERSTELLE FÜR MEDIZINPRODUKTE GMBH AN DER TECHNISCHEN UNIVERSITÄT BERLIN
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive 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 1105: Active ophthalmologic 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 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 1402: Devices utilising non-ionizing radiation
MD 1403: Devices for hyperthermia / hypothermia
Horizontal Technical Competence
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 III: EC-Type Examination
MDD ANNEX IV: EC Verification
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance