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

confirming that Heinz Herenz Medizinalbedarf GmbH has introduced

Purchase, storage, distribution and final inspection of medical devices and general medical supplies to

Certificate QS - 1249
Blood bags, blood lancets, allergy lancets, intravenous cannulas, disposable gloves, steristoppers, cotton swabs, bacterial sample collecting sets, ECG-electrodes, aneroid sphygmomanometers, medicine cups, laboratory glassware, disposables, pipette tips microscopic slides, cover glasses, haemacytometer, brushes for gynaecological sample taking, covers for sonography sondes, gynaecological accessories, ultrasound gel, pipettes of all types, protective clothes, plastic containers, urine cups, blood collection tubes, razors disposable, alcohol swabs, test strips, capillary tubes, laboratory ware, tongue depressors, stethoscopes, tourniquets, hot-/cold wraps, instruments, thermometers, disinfectants, 3-way-stopcocks, transfusion sets, sterile single use forceps.

A Quality Audit demonstrated compliance of the Quality Management System with
EN ISO 13485:2012 + AC:2012

EC Certificate of Conformity

to introduced and applies a Quality Management System for the aspects of manufacture concerned with securing and maintaining sterile conditions for the products / product categories

Bacterial sample collecting sets, mouth spatulas, surgical covers, examination gloves, cotton swabs, single use forceps

An Audit demonstrated compliance of the Quality Management System with Annex V of the Council Directive 93/42/EEC concerning Medical Devices.

EC Certificate of Conformity

to introduced and applies a Quality Management System for the manufacturing process designed to secure and maintain sterility for the products / product categories

Transfusion sets, 3-way stopcocks

An Audit demonstrated compliance of the Quality Management System with Annex V of the Council Directive 93/42/EEC concerning Medical Devices.

EC Certificate of Conformity

to introduced and applies a Quality Management System for the manufacturing process designed to secure and maintain sterility for the products / product categories

Blood bags, blood lancets, allergy lancets, intravenous cannulas, scalpell blades, single use scalpells, stitch cutter, disinfectants

An Audit demonstrated compliance of the Quality Management System with Annex V of the Council Directive 93/42/EEC concerning Medical Devices.

EC Certificate of Conformity

to introduced and applies a Quality Management System for the manufacturing process designed to secure and maintain sterility for the products / product categories

Aneroid sphygmomanometers, medicine cups

An Audit demonstrated compliance of the Quality Management System with Annex V of the Council Directive 93/42/EEC concerning Medical Devices.