ECM GMBH

ECM-ZERTIFIZIERUNGSGESELLSCHAFT FÜR MEDIZINPRODUKTE IN EUROPA MBH
Bismarckstraße 106
52066 AACHEN
Country : Germany
Phone : +49:241:5010 34
Fax : +49:241:5010 38
Email : ecm@medi-online.com
Notified Body number : 0481
Website : ECM-ZERTIFIZIERUNGSGESELLSCHAFT FÜR MEDIZINPRODUKTE IN EUROPA MBH

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 0105: Non-active ophthalmologic devices
MD 0106: Non-active instruments
MD 0107: Contraceptive medical devices
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0109: Non-active devices for in vitro fertilsation and assisted reproductive technologies
MD 0201: Non-active cardiovascular implants
MD 0202: Non-active orthopedic implants
MD 0203: Non-active functional implants
MD 0204: Non-active soft tissue implants
MD 0301: Bandages and wound dressings
MD 0302: Suture material and clamps
MD 0303: Other material for wound care
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants

Horizontal Technical Competence
MDS 7001: Medical devices incorporating medicinal substances
MDS 7002: Medical devices utilising tissues of animal origin
MDS 7006: Medical devices in sterile condition
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX III: EC-Type Examination
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance