More for you
Certificates
Please contact us for information on known characteristics and technical factors that could pose a hazard if the product were reused.
More for you
ISO certificate
MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH certifies that the company Heinz Herenz Medizinalbedarf GmbH
has introduced, applies and maintains a quality management system.
An audit provided evidence that the quality management system meets the requirements of the standard mentioned below:
EN ISO 13485:2016
This is monitored by MEDCERT.
Certificate in
Development, production, final inspection and distribution of medical devices
Intravenous catheters, blood and allergy lancets, scalpel blades, disposable scalpels, thread knives, protective sheaths for sonography probes, ECG electrodes
Distribution of medical devices and medical supplies
Blood bags, collection cups, sterile disposable forceps, cold-immediate compresses
Production, final inspection and distribution of medical devices
3-way stopcocks, transfusion sets, digital clinical thermometers, instruments, venous tourniquets, ultrasound gels, gynecology supplies, alcohol swabs, protective clothing, blood counting chambers, disposable items, urine bottles and cups, gynecological swab brushes, disposable razors, blood collection tubes, capillary tubes, plastic cups, cold-hot compresses, stethoscopes, mechanical sphygmomanometers, sterile and non-sterile oral spatulas, sterile cotton swabs, sterile swabs, sterile urine bags, sterile surgical drapes.
IS0 certificate
EC Certificate of Conformity
that Heinz Herenz Medizinalbedarf GmbH for the products / product categories
Blood and allergy lancets, intravenous catheters, scalpel blades, disposable scalpels, suture knives
has introduced, applies and maintains a quality assurance system.
An audit has been performed to demonstrate that this quality system meets the requirements of Council Directive 93/42/EEC as stated below:
Annex II without consideration of section 4
This is monitored by MEDCERT.
EC Certificate of Conformity
EC Certificate of Conformity
that Heinz Herenz Medizinalbedarf GmbH for the products / product categories
3-way stopcocks, transfusion sets, digital clinical thermometers
has introduced, applies and maintains a quality assurance system.
An audit has been performed to demonstrate that this quality system meets the requirements of Council Directive 93/42/EEC as stated below:
Appendix V
This is monitored by MEDCERT.
EC Certificate of Conformity
EC Certificate of Conformity
that Heinz Herenz Medizinalbedarf GmbH for the products / product categories
Mechanical blood pressure monitors
has implemented, applies and maintains a quality assurance system related to the conformity of the products with the metrological requirements .
This is monitored by MEDCERT.
By means of an audit, proof was provided that this quality assurance system fulfills the requirements of Directive 93/42/ EEC mentioned below:
Appendix V
EC Certificate of Conformity
EC Certificate of Conformity
that Heinz Herenz Medizinalbedarf GmbH for the products / product categories
Swabs, mouth spatulas, surgical drapes, cotton swabs, urine bags
has implemented, applies and maintains a quality assurance system for the manufacturing steps related to sterilization and maintenance of sterility. This is monitored by MEDCERT.
An audit has been performed to demonstrate that this quality system meets the requirements of Directive 93/42/EEC as stated below:
Appendix
EC Certificate of Conformity
