05055272719551

Slit Lamp

Keeler Ltd·Class I·EU EUDAMED·Trade name: SLZ 3XC LED - PLATE SYSTEMYes
Device classification
Risk class
Class I
CND nomenclatures code
Z12120108
Trade name
SLZ 3XC LED - PLATE SYSTEM
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05055272719551
Basic UDI
50552727SLITLAMPSRG
Version date
November 20, 2024
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Belgium
Market available
Belgium:2024-09-26~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SLIT LAMPS

About this record

Access comprehensive regulatory information for Slit Lamp in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 05055272719551 and manufactured by Keeler Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (SLZ 3XC LED - PLATE SYSTEM), 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.