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.

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 implemented, applies and maintains a quality system.
An audit has demonstrated that this quality system complies with the requirements of Council Directive 93/42/EEC as specified below:
Annex II without taking into account section 4
This is monitored by MEDCERT.

EC Certificate of Conformity

that Heinz Herenz Medizinalbedarf GmbH for the products / product categories

3-way stopcocks, transfusion sets, digital clinical thermometers

has implemented, applies and maintains a quality system.
An audit has demonstrated that this quality system complies with the following requirements of Council Directive 93/42/EEC:
Annex V
This is monitored by MEDCERT.

EC Certificate of Conformity

that Heinz Herenz Medizinalbedarf GmbH for the products / product categories

Mechanical blood pressure monitors

has established, implements and maintains a quality system in relation to the conformity of the products with the metrological requirements .
This is monitored by MEDCERT.
An audit has demonstrated that this quality system complies with the requirements of Directive 93/42/EEC listed below:
Annex V

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 demonstrated that this quality assurance system complies with the requirements of Directive 93/42/EEC listed below:
Annex

EC Certificate of Conformity

Notified Body Confirmation Letter

Notified Body Confirmation Letter concerning the CE certificates 1249GB410190513 (Annex II) and 1249GB415190513 (Annex V):

Certification No: 1249GB454241115

Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Hamburg Chamber of Commerce

Certificate 2024
Dual training