Device for single use:
Please contact us to get information on known characteristics and technical factors that could pose a risk if the device were to be re-used.
ISO-Certificate
MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH
herewith confirms that the company
Heinz Herenz Medizinalbedarf GmbH
With its facility as per attachment 1
has introduced, applies and maintains a Quality Management System in the area of:
Design, manufacture, final inspection and distribution of
Intravenous cannulas, Blood- and allergy lancets, Scalpel blades, Single use scalpels, Stitch cutters, Covers for sonography sondes, ECG-electrodes
Distribution of
Blood bags, Medicine cups, Sterile single use forceps, Emergency cold wraps
Manufacture, final inspection and distribution of
3-way-stopcocks, Transfusion sets, Digital thermometers, Instruments, Tourniquets, Ultrasound gel, Gynaecological accessories, Alcohol swabs, Protective clothes, Haemacytometer, Disposables, Urine bottles and cups, Brushes for gynaecological sample taking, Disposable razors, Blood collection tubes, Capillary tubes, Plastic containers, Cold-/hot wraps, Stethoscopes, Aneroid sphygmomanometers, Sterile and non-sterile Tongue depressors, Sterile cotton swabs, Sterile bacterial sample collecting sets, Sterile urine bags, Sterile urgical covers
The compliance of the Quality Management System with the requirements of the below mentioned
standard was verified by an audit:
EN ISO 13485:2016
The license of certification is subject to surveillance by MEDCERT.
EC-Certificate of Conformity
has introduced, applies and maintains a quality assurance system for the products / product categories:
Blood and allergy lancets, lntravenous cannulas, Scalpell blades, Single use scalpels, Stitch cutter
The compliance of the quality assurance system with the below mentioned requirements of the
Council Directive 93/ 42/EEC was verified by an audit:
Annex II excluding section 4
This certification is subject to surveillance by MEDCERT.
EC-Certificate of Conformity
has introduced, applies and maintains a quality assurance system for the products / product categories:
Transfusion sets, 3-way-stopcocks, Digital thermometers
The compliance of the quality assurance system with the below mentioned requirements of the
Council Directive 93/42/EEC was verified by an audit:
Annex V
This certification is subject to surveillance by MEDCERT.
EC-Certificate of Conformity
has introduced, applies and maintains a Quality Assurance System concerning the conformity of the medical devices with the metrological requirements for the
products / product categories:
Aneroid sphygmomanometers
The compliance of the Quality Assurance System with the below mentioned requirements of the
Council Directive 93/42/EEC was verified by an audit:
Annex V
The license of certification is subject to surveillance by MEDCERT.
EC-Certificate of Conformity
has introduced, applies and maintains a Quality Assurance System for the aspects of manufacture
concerned with securing and maintaining sterile conditions
for the products / product categories:
Bacterial sample collecting sets, Tongue depressors, Surgical covers, Cotton swabs, Urine bags
The compliance of the Quality Assurance System with the below mentioned requirements of the
Council Directive 93/42/EEC was verified by an audit:
Annex V
The license of certification is subject to surveillance by MEDCERT.
