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СЕРТИФИКАТЫ
Device for single use:
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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
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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 13485:2003 + AC:2009
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Download Certificate |
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EC Certificate of Conformity |
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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.
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Download Certificate |
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EC Certificate of Conformity |
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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.
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Download Certificate |
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EC Certificate of Conformity |
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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 II
of the Council Directive 93/42/EEC concerning Medical
Devices.
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Download Certificate |
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EC Certificate of Conformity |
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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 VI
of the Council Directive 93/42/EEC concerning Medical
Devices.
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Download Certificate |
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