{"id":3288,"date":"2023-01-26T10:49:06","date_gmt":"2023-01-26T08:49:06","guid":{"rendered":"https:\/\/p628212.webspaceconfig.de\/certificates\/"},"modified":"2025-06-26T10:00:24","modified_gmt":"2025-06-26T08:00:24","slug":"certificates","status":"publish","type":"page","link":"https:\/\/www.herenz.de\/en\/certificates\/","title":{"rendered":"Certificates"},"content":{"rendered":"
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\n\t\t\t\"Medizinalbedarf\n\t\t<\/div>\n\t\n\t
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More for you<\/h1>\n\t\t\t\n\t\t\t\t\t\t\t

Certificates<\/h2>\n\t\t\t\n\t\t\t\t\t\t\t

Please contact us for information on known characteristics and technical factors that could pose a hazard if the product were reused.<\/p>\n\t\t\t\n\t \n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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ISO certificate<\/h3>\n\n\n\n

MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH certifies that the company Heinz Herenz Medizinalbedarf GmbH<\/strong>
has introduced, applies and maintains a quality management system.<\/p>\n\n\n\n

An audit provided evidence that the quality management system meets the requirements of the standard mentioned below:<\/p>\n\n\n\n


EN ISO 13485:2016<\/strong>
This is monitored by MEDCERT.<\/p>\n\n\n\n

Certificate in <\/p>\n\n\n\n

Development, production, final inspection and distribution of medical devices <\/h4>\n\n\n\n

Intravenous catheters, blood and allergy lancets, scalpel blades, disposable scalpels, thread knives, protective sheaths for sonography probes, ECG electrodes<\/p>\n\n\n\n

Distribution of medical devices and medical supplies<\/h4>\n\n\n\n

Blood bags, collection cups, sterile disposable forceps, cold-immediate compresses<\/p>\n\n\n\n

Production, final inspection and distribution of medical devices<\/h4>\n\n\n\n

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.<\/p>\n<\/div>\n\n\n\n

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\"Certificate<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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IS0 certificate<\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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EC Certificate of Conformity <\/h3>\n\n\n\n

that Heinz Herenz Medizinalbedarf GmbH for the products \/ product categories
<\/p>\n\n\n\n

Blood and allergy lancets, intravenous catheters, scalpel blades, disposable scalpels, suture knives
<\/h4>\n\n\n\n

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<\/strong> as specified below:
Annex II without taking into account section 4
This is monitored by MEDCERT.<\/p>\n\n\n\n

<\/a><\/p>\n<\/div>\n\n\n\n

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\"Certificate<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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\n \"download\n <\/div>\n\n
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EC Certificate of Conformity <\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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EC Certificate of Conformity <\/h3>\n\n\n\n

that Heinz Herenz Medizinalbedarf GmbH for the products \/ product categories
<\/p>\n\n\n\n

3-way stopcocks, transfusion sets, digital clinical thermometers
<\/h4>\n\n\n\n

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<\/strong>:
Annex V
This is monitored by MEDCERT.<\/p>\n\n\n\n

<\/a><\/p>\n<\/div>\n\n\n\n

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\"EC<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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\n \"download\n <\/div>\n\n
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EC Certificate of Conformity <\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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EC Certificate of Conformity <\/h3>\n\n\n\n

that Heinz Herenz Medizinalbedarf GmbH for the products \/ product categories
<\/p>\n\n\n\n

Mechanical blood pressure monitors
<\/h4>\n\n\n\n

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

<\/a><\/p>\n<\/div>\n\n\n\n

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\"Certificate<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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\n \"download\n <\/div>\n\n
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EC Certificate of Conformity <\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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EC Certificate of Conformity <\/h3>\n\n\n\n

that Heinz Herenz Medizinalbedarf GmbH for the products \/ product categories
<\/p>\n\n\n\n

Swabs, mouth spatulas, surgical drapes, cotton swabs, urine bags
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has implemented, applies and maintains a quality assurance system for the manufacturing steps related to sterilization and maintenance of sterility<\/strong>. This is monitored by MEDCERT.
An audit has demonstrated that this quality assurance system complies with the requirements of Directive 93\/42\/EEC<\/strong> listed below:
Annex<\/p>\n\n\n\n

<\/a><\/p>\n<\/div>\n\n\n\n

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\"EC<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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\n \"download\n <\/div>\n\n
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EC Certificate of Conformity <\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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EC Certificate of Conformity <\/h3>\n\n\n\n

Notified Body Confirmation Letter<\/strong><\/p>\n\n\n\n

Notified Body Confirmation Letter concerning the CE certificates 1249GB410190513 (Annex II) and 1249GB415190513 (Annex V):<\/p>\n\n\n\n

Certification No: 1249GB454241115<\/strong><\/p>\n\n\n\n

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<\/p>\n\n\n\n

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\"EC<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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\n \"download\n <\/div>\n\n
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EC Certificate of Conformity <\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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Hamburg Chamber of Commerce<\/h3>\n\n\n\n

Certificate 2024
Dual training<\/p>\n\n\n\n

<\/a><\/p>\n<\/div>\n\n\n\n

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\"\"<\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n
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Chamber of Commerce Certificate<\/p>\n

pdf<\/p>\n <\/div>\n\n <\/div>\n

\n \n Download<\/span>\n <\/a>\n <\/div>\n <\/div>\n<\/div><\/div>\n\n\n
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<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"ISO certificate MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH certifies that the company Heinz Herenz Medizinalbedarf GmbHhas 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 13485:2016This is monitored by MEDCERT. Certificate in Development, production, final… View Article<\/a>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-3288","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nCertificates - Heinz Herenz<\/title>\n<meta name=\"description\" content=\"Quality assurance through EC certificate of conformity & ISO certificates. 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