Omega Pharma International NV

SRN

BE-MF-000007210

Role

Manufacturer

Country

Belgium

Organization name

Omega Pharma International NV

EU VAT number

0807.596.363

EORI

BE0807596363

Trade register

0807596363

Date of registration

Jun 10, 2021

Address

6, GASTON CROMMENLAAN BOX 606 9050 GHENT BELGIUM

Email

QAMeddev@perrigo.com

Name

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

SRN

BE-CA-007

Phone

+32 2 528 40 00

Email

notifications.meddev@fagg-afmps.be

• TOLLEY Josephine
  Ensure that Technical documentation and EU declaration of conformity are drawn up and kept up-to-date Sign off Regulatory Affairs related non-conformities (eg Technical file discrepancies, RA procedure related non-conformities,...)
  Hidden
• PASTOR Caroline
  Compliance with Post Marketing Surveillance obligations in accordance with EU MDR Art. 10(10) Fulfillment of reporting obligations referred to in EU MDR Articles 87 to 91 Sign off Safety related non-conformities
  Hidden
• DAUDE Gaelle
  Appropriate check of the conformity of the devices, in accordance with the quality management system under which the devices are manufactured, before a device is released. Sign off Quality Assurance related non-conformities ( eg Production related findings, Out of specifications, Release/Rework/quarantine shipment, Supply, Quality Complaints) Sign off MCRM (Monthly Review of Quality Complaints)
  Hidden
• ARTUS-ARDUISE Cécile
  Sign off documentation related to investigational devices as per EU MDR Section 4.1 of Chapter II of Annex XV requirement:
  Hidden

No certificates registered for this manufacturer.

Devices placed in 18 countries

• Italy6
• Belgium5
• Czechia5
• France5
• Portugal5
• EL4
• Hungary4
• Bulgaria2
• Spain2
• Slovenia2
• XI2
• Austria1
• Finland1
• Croatia1
• Ireland1
• Latvia1
• Poland1
• Romania1

No devices registered for this manufacturer.