Galena Pharma Oy

SRN

FI-MF-000000588

Role

Manufacturer

Country

Finland

Organization name

Galena Pharma Oy

EU VAT number

1057172-0

Date of registration

Jan 11, 2021

Address

10, SAMMONKATU 70500 KUOPIO FINLAND

Email

galena@galena.fi

Website

www.galena.fi

Name

Finnish Medicines Agency, Supervision and licences, Medical Device Unit

SRN

FI-CA-006

Phone

+358 29 522 3341

Email

registry@fimea.fi

• MAUNU Piritta
  (b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV. Deputy:(a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing.
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• HEIKKINEN Inka
  (a) the conformity of the devices is appr. checked, in accordance with the QMS under which the devices are manufactured, before releasing. Deputy: (b) the technical documentation and the EU DoC are drawn up and kept up-to-date;(c) the PMS obligations are complied ref. Art. 10(10);(d) the reporting obligations ref. to in Art. 87 to 91 are fulfilled; ref. to vigilance reporting.(e) in the case of investigational devices, the statement ref. to Annex XV.
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Devices placed in 5 countries

• Finland66
• Romania4
• Sweden4
• Germany3
• Norway2

Showing 51–75 of 79 devices.