Statistics for OPI

49Total Devices

8Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

18Countries

Certificate health for OPI

No certificates registered for this manufacturer.

Showing 26–49 of 49 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Paranix Express Lotion + Peigne	`CT33797`	`05400951005386`	2	On the market
Paranix Express Shampooing + Peigne	`CT33786`	`05400951005379`	2	On the market
Paranix Express Shampooing + Peigne	`CT33785`	`05400951005362`	2	On the market
CT33680	`CT33680`	`05400951005294`	2	On the market
CT32084	`CT32084`	`05400951005102`	1	On the market
CT32087	`CT32087`	`05400951005409`	2	On the market
CT32082	`CT32082`	`05400951005133`	1	On the market
CT32088	`CT32088`	`05400951005232`	2	On the market
CT28861	`CT28861`	`05400951004976`	2	On the market
CT29992	`CT29992`	`05400951005485`	2	On the market
CT32161	`CT32161`	`05400951005454`	2	On the market
Paranix Shampoing/Shampoo + Peigne/Kamm	`CT30028`	`05400951005355`	2	On the market
Paranix Shampoing/Shampoo + Peigne/Kamm	`CT30027`	`05400951005348`	2	On the market
CT28829	`CT28829`	`05400951005591`	2	On the market
CT29997	`CT29997`	`05400951005119`	2	On the market
CT29998	`CT29998`	`05400951005003`	2	On the market
CT29999	`CT29999`	`05400951005034`	2	On the market
CT31511	`CT31511`	`05400951005430`	2	On the market
CT30033	`CT30033`	`05400951005058`	2	On the market
CT30032	`CT30032`	`05400951004983`	2	On the market
CT28089	`CT28089`	`05400951001197`	1	On the market
CT28086	`CT28086`	`08470002055292`	1	On the market
XLS Medical Pro 7 gélules	`CT30783`	`05400951001104`	1	On the market
CT28087	`CT28087`	`08470002055094`	1	On the market

Devices placed in 18 countries

EUDAMED update: Dec 17, 2025

BE-MF-000007210

Active

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