EUDAMED update: Dec 17, 2025

Omega Pharma International NV

BE-MF-000007210

Active49 devices

Address: Gaston Crommenlaan, 6 9050 Ghent
Role: Manufacturer
Date of registration: Jun 10, 2021
Country: Belgium

Omega Pharma International NV is a medical device manufacturer registered in EUDAMED. The company has 49 devices on the EU market across 25 countries. It holds 1 valid CE certificate. Headquartered in Ghent, Belgium. Explore the regulatory profile, devices and certificates on MD Atlas.

About OPI

: 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

Contact details for OPI

Email: QAMeddev@perrigo.com
Address: 6, GASTON CROMMENLAAN BOX 606 9050 GHENT BELGIUM

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of OPI

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

Data export

Export the 49 devices of OPI

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Paranit Šampon + Hřeben	Paranit Šampon + Hřeben	`CT29976`	`05400951005225`	2	On the market
Paranix Express Sampon + Fésűo + Kam	Paranix Express Sampon + Fésűo + Kam	`CT32160`	`05400951005270`	2	On the market
Paranix Extra Strong Shampoo/Shampoing + Kam	Paranix Extra Strong Shampoo/Shampoing + Kam	`CT26571`	`05400951005324`	2	On the market
Paranix ΣΑΜΠΟΥΑΝ + ΧΤΕΝΑ	Paranix ΣΑΜΠΟΥΑΝ + ΧΤΕΝΑ	`CT30030`	`05400951005096`	2	On the market
XLS Medical Pro 7	XLS Medical Pro 7	`CT28088`	`05400951001180`	1	On the market
Lyclear Express Shampoo + Comb	Lyclear Express Shampoo + Comb	`CT23524`	`05400951005140`	2	On the market
Lyclear Lotion + Comb	Lyclear Lotion + Comb	`CT08439`	`05400951005188`	1	On the market
Lyclear Original Shampoo + Comb	Lyclear Original Shampoo + Comb	`CT20914`	`05400951005157`	2	On the market
Paranit Fejtetű Megelőző Sampon	Paranit Fejtetű Megelőző Sampon	`BL28796`	`05400951003429`	1	On the market
Paranit Šampón + Hrebeň	Paranit Šampón + Hrebeň	`CT29972`	`05400951005218`	2	On the market
Paranit Šampūns +Kemme	Paranit Šampūns +Kemme	`CT29975`	`05400951005010`	2	On the market
Paranit Express Šampon + češalj	Paranit Express Šampon + češalj	`CT32155`	`05400951005560`	2	On the market
Paranit Express Šampón + Hrebeň	Paranit Express Šampón + Hrebeň	`CT32158`	`05400951005201`	2	On the market
Paranit Express Шампоан + гребен	Paranit Express Шампоан + гребен	`CT32156`	`05400951005577`	2	On the market
Paranit kezelő sampon + fésű	Paranit kezelő sampon + fésű	`CT30031`	`05400951005287`	2	On the market
Paranit Šampon + Glavnik	Paranit Šampon + Glavnik	`CT29980`	`05400951005263`	2	On the market
Paranit Shampoo + Comb	Paranit Shampoo + Comb	`CT29981`	`05400951005256`	2	On the market
Paranit Sprej + Hřeben	Paranit Sprej + Hřeben	`CT30648`	`05400951005249`	2	On the market
ParanitPršilo + Glavnik	ParanitPršilo + Glavnik	`CT29956`	`05400951005584`	2	On the market
Paranix Champô Proteção Contra Piolhos	Paranix Champô Proteção Contra Piolhos	`1000017169 BL`	`05400951003443`	1	On the market
Paranix Express Spray + Pente	Paranix Express Spray + Pente	`CT32081`	`05400951005065`	2	On the market
Paranix Express Loção + Pente	Paranix Express Loção + Pente	`CT32080`	`05400951005072`	2	On the market
Paranix Express ΣΑΜΠΟΥΑΝ + Ktena	Paranix Express ΣΑΜΠΟΥΑΝ + Ktena	`CT32159`	`05400951005089`	2	On the market
Paranix Express Champô + Pente	Paranix Express Champô + Pente	`CT32090`	`05400951005041`	2	On the market
Paranix Express Lotion + Peigne	Paranix Express Lotion + Peigne	`CT33797`	`05400951005386`	2	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Paranit Šampon + Hřeben	Paranit Šampon + Hřeben	`CT29976`	`05400951005225`	2	On the market
Paranix Express Sampon + Fésűo + Kam	Paranix Express Sampon + Fésűo + Kam	`CT32160`	`05400951005270`	2	On the market
Paranix Extra Strong Shampoo/Shampoing + Kam	Paranix Extra Strong Shampoo/Shampoing + Kam	`CT26571`	`05400951005324`	2	On the market
Paranix ΣΑΜΠΟΥΑΝ + ΧΤΕΝΑ	Paranix ΣΑΜΠΟΥΑΝ + ΧΤΕΝΑ	`CT30030`	`05400951005096`	2	On the market
XLS Medical Pro 7	XLS Medical Pro 7	`CT28088`	`05400951001180`	1	On the market
Lyclear Express Shampoo + Comb	Lyclear Express Shampoo + Comb	`CT23524`	`05400951005140`	2	On the market
Lyclear Lotion + Comb	Lyclear Lotion + Comb	`CT08439`	`05400951005188`	1	On the market
Lyclear Original Shampoo + Comb	Lyclear Original Shampoo + Comb	`CT20914`	`05400951005157`	2	On the market
Paranit Fejtetű Megelőző Sampon	Paranit Fejtetű Megelőző Sampon	`BL28796`	`05400951003429`	1	On the market
Paranit Šampón + Hrebeň	Paranit Šampón + Hrebeň	`CT29972`	`05400951005218`	2	On the market
Paranit Šampūns +Kemme	Paranit Šampūns +Kemme	`CT29975`	`05400951005010`	2	On the market
Paranit Express Šampon + češalj	Paranit Express Šampon + češalj	`CT32155`	`05400951005560`	2	On the market
Paranit Express Šampón + Hrebeň	Paranit Express Šampón + Hrebeň	`CT32158`	`05400951005201`	2	On the market
Paranit Express Шампоан + гребен	Paranit Express Шампоан + гребен	`CT32156`	`05400951005577`	2	On the market
Paranit kezelő sampon + fésű	Paranit kezelő sampon + fésű	`CT30031`	`05400951005287`	2	On the market
Paranit Šampon + Glavnik	Paranit Šampon + Glavnik	`CT29980`	`05400951005263`	2	On the market
Paranit Shampoo + Comb	Paranit Shampoo + Comb	`CT29981`	`05400951005256`	2	On the market
Paranit Sprej + Hřeben	Paranit Sprej + Hřeben	`CT30648`	`05400951005249`	2	On the market
ParanitPršilo + Glavnik	ParanitPršilo + Glavnik	`CT29956`	`05400951005584`	2	On the market
Paranix Champô Proteção Contra Piolhos	Paranix Champô Proteção Contra Piolhos	`1000017169 BL`	`05400951003443`	1	On the market
Paranix Express Spray + Pente	Paranix Express Spray + Pente	`CT32081`	`05400951005065`	2	On the market
Paranix Express Loção + Pente	Paranix Express Loção + Pente	`CT32080`	`05400951005072`	2	On the market
Paranix Express ΣΑΜΠΟΥΑΝ + Ktena	Paranix Express ΣΑΜΠΟΥΑΝ + Ktena	`CT32159`	`05400951005089`	2	On the market
Paranix Express Champô + Pente	Paranix Express Champô + Pente	`CT32090`	`05400951005041`	2	On the market
Paranix Express Lotion + Peigne	Paranix Express Lotion + Peigne	`CT33797`	`05400951005386`	2	On the market

Omega Pharma International NV

About OPI

Contact details for OPI

Competent authority

Officers and regulatory representatives of OPI

Export the 49 devices of OPI

Related searches

About OPI

Contact details for OPI

Competent authority

Officers and regulatory representatives of OPI

Statistics for OPI

Certificate health for OPI

Related documents

Devices by risk class

Device catalog for OPI

Device families (Basic UDI-DI) of OPI

Market presence of OPI

Export the 49 devices of OPI

Related searches

Market presence of OPI

Devices by risk class

Related documents

Device families (Basic UDI-DI) of OPI

Statistics for OPI

Certificate health for OPI

Device catalog for OPI