PaloDEx Group Oy

SRN

FI-MF-000004943

Role

Manufacturer

Country

Finland

Organization name

PaloDEx Group Oy

EU VAT number

FI19774137

EORI

FI1977413-7

Trade register

1977413-7

Date of registration

May 26, 2021

Address

160, NAHKELANTIE FI-04300 TUUSULA FINLAND

Email

regulatory@dexis.com

Name

Finnish Medicines Agency, Supervision and licences, Medical Device Unit

SRN

FI-CA-006

Phone

+358 29 522 3341

Email

registry@fimea.fi

• HARJUNPÄÄ Rainer
  - The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -The reporting obligations are referred to in Articles 87 and 91 are filled. -In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II or Annex XV is issued.
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• NOUSIAINEN Päivi
  -The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. -The post-market surveillance obligations are completed with in accordance with Article 10(10).
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No devices registered for this manufacturer.

Devices placed in 1 country

• Finland75