Production sites & Certificates

Production site in Birkenfeld: 

Eurofins Inpac Medizintechnik GmbH

Gewerbestr. 34

75217 Birkenfeld, Germany

Quality management

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

FDA registration (US)

 Owner-Operator Number: 10043226

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

MHLW registration (Japan)

• certificates 2024 till 2029 (PDF)

Production site in Calw:

Eurofins Steripac GmbH

Oberreichenbacher Str. 15-17

75365 Calw, Germany 

Quality management

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

FDA registration (US)

 Owner-Operator Number:

• Establishment Number: 3009217531

MHLW registration (Japan)

• certificates 2021 till 2026 (PDF)