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.

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IS0 certificate

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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.

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EC Certificate of Conformity

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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.

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EC Certificate of Conformity

pdf

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

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EC Certificate of Conformity

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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

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EC Certificate of Conformity

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Hamburg Chamber of Commerce

Certificate 2018
Dual education