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Regulatory Documents


Regulatory Documents


Herrsching Facility Germany


Medical Device Directive 93/42/EEC

ISO 13485 Certificate

ISO 13485 Certificate addendum (containing list of certified facilities)



Murrysville Facility USA (Pittsburgh)


Medical Device Directive 93/42/EEC

ISO 13485 Certificate


UK: only for Respiratory Drug Delivery Products


Medical Device Directive 93/42/EEC

ISO 13485 Certificate


CE certificates devices

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