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About Eurofins Inpac Medizintechnik GmbH

Eurofins Inpac Medizintechnik GmbH is a specialised full-service partner for industrial processing, sterilisation and packaging of medical devices. The company supports its customers from the development stage through comprehensive consulting and development services and offers an integrated range of services including cleaning and cleanroom assembly, development and manufacturing of validated packaging solutions including packaging validation and testing, as well as labelling and documentation in accordance with international regulatory requirements (e.g. MDR, ISO 13485 and ISO 11607).
Both in-house and coordinated sterilisation processes, together with comprehensive laboratory testing, ensure product safety and regulatory compliance across the entire value chain.
With its one-stop-shop approach, Eurofins Inpac supports manufacturers to bring safe, compliant, and market-ready medical devices to market efficiently from a single source.

Locations

Birkenfeld

Laboratory

Neureuthstraße 4, 75217 Birkenfeld, Germany

Laboratory

Birkenfeld

Laboratory

Gewerbestraße 34, 75217 Birkenfeld, Germany

Laboratory

Accreditations

Issuing Body Deutsche Akkreditierungsstelle GmbH

Issuing Body Country GERMANY

Issuing Body Website https://www.dakks.de/

Certificates

Quality management

EN ISO 13485:2016 incl. AC:2018 + A11:2021 (PDF)

FDA registration (USA)

Owner-Operator Number: 10043226

Establishment Number: 3007515069 (Gewerbestraße)
Establishment Number: 3013111980 (Neureutstraße)

MHLW registration (Japan)

certificates 2024 till 2029 Gewerbestr. / Neureutstr. (PDF) (to come)