DEKRA Certification B.V.
Meander 1051 / P.O. Box 5185
6825 MJ ARNHEM / 6802 ED ARNHEM
Country : Netherlands
Phone : +31:(0)88 968 3606
Fax : +31:(0)88 968 3100
Email : product.certification@dekra.com
Notified Body number : 0344
Website : DEKRA Certification B.V.
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
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
IVD Medical Device Accreditation
IVD 0101: ABO System
IVD 0102: Rhesus (C,c,D,E,e)
IVD 0103: Anti-Kell
IVD 0201: HIV Infection
IVD 0202: HTLV I and II
IVD 0203: Hepatitis B, C and D
IVD 0301: Anti-Duffy and anti-Kidd
IVD 0302 Irregular anti-erythrocytic antibodies
IVD 0303: Congenital infections: rubella, toxoplasmosis
IVD 0304: Hereditary disease: phenylketouria
IVD 0305: Human infections: cytomegalovirus, chlamidia
IVD 0306: HLA tissue groups: DR, A, B
IVD 0307: Tomoral marker: PSA
IVD 0308: Risk of trisomy 21
IVD 0309: Device for self-diagnosis for ,easurement of blood sugar
IVD 0401: Clinical chemistries (Self-Testing)
IVD 0402: Hematology (Self-Testing)
IVD 0403: Immunology (Self-Testing)
IVD 0404: Molecular biology (Self-Testing)
IVD 0405: Pregnancy and ovulation (Self-Testing)
IVD 0406: Speciment recepticles (Self-Testing)
Horizontal Technical Competence
MDS 7206: IVDs in sterile condition
MDS 7207: IVDs utilizing micromechanics
MDS 7208: IVDs utilising nanomaterials
MDS 7209: IVDs utilising biological active coatings and/or materials
MDS 7210: IVDs utilising material of human origin
ANNEXES
ANNEX IV: Full Quality Assurance System
ANNEX V: EC Type-Examination
ANNEX VI: EC-Verification
ANNEX VII: Production Quality Assurance