Gespräch_vorab_8005833-72dpi

 

Tübingen Regional Council:

Manufacturing authorisation of medicinal products in accordance with § 13 para. 1

> Herstellungserlaubnis Humanarzneimittel,   PDF (240 KB)

> GMP Zertifikat,   PDF (350 KB)

 

DEKRA certificate for quality management, field:

Services in the areas of cleaning, assembling and packaging medical products as well as the development and validation of sterile barrier systems

> Certificate EN ISO 13485:2016 No. 50871-14-00 _ E.pdf

> Zertifikat EN ISO 13485:2016 Nr. 50871-14-00 _ D.pdf

> Certificat EN ISO 13485:2016 No. 50871-14-00 _ F.pdf

 

International certificates

Japanese Ministry of Health: Pharmaceutical Affairs Act, § 13-3

> Accreditation certificate of foreign drug manufacturer, PDF (125 KB)

> Accrediation cerificate of medical device manufacturer, PDF (130 KB)

 

FDA Registration

Registration Number: 3009217531

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