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 1–25 of 49 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
CT29976	`CT29976`	`05400951005225`	2	On the market
CT32160	`CT32160`	`05400951005270`	2	On the market
CT26571	`CT26571`	`05400951005324`	2	On the market
CT30030	`CT30030`	`05400951005096`	2	On the market
CT28088	`CT28088`	`05400951001180`	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