05055272719674

532nm LIO

Keeler Ltd·Class IIb·EU EUDAMED·Trade name: 532nm LIOYes
Device classification
Risk class
Class IIb
CND nomenclatures code
Z12120199
Trade name
532nm LIO
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05055272719674
Basic UDI
B-05055272719674
Version date
March 04, 2025
Manufacturer last update
September 10, 2024
Active status
Yes
Manufacturer
Manufacturer name
Keeler Ltd
Country
United Kingdom (ex Northern Ireland)
Country type
NON_EU
Address
Clewer Hill Road Windsor
Email
regulatory@keeler.co.uk
Authorized representative
SRN
ES-AR-000001559
Country
Spain
Address
453 Colom, Terrassa
Email
info@visiometrics.com
Regulatory information
Competent authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Netherlands
Market available
Denmark:2020-03-13~None, Netherlands:2019-11-14~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

About this record

Access comprehensive regulatory information for 532nm LIO in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 05055272719674 and manufactured by Keeler Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (532nm LIO), manufacturer information, authorized representative details, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.