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Ophthalmoscope - EUDAMED Registration 05055272701792

Access comprehensive regulatory information for Ophthalmoscope 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 05055272701792 and manufactured by Keeler Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (3.6V PROFESSIONAL OPHTH & LITHIUM CHARGER), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola 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.

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EUDAMED Official Data
Class I
05055272701792
Yes
Ophthalmoscope
Trade Name: 3.6V PROFESSIONAL OPHTH & LITHIUM CHARGER
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Device Description (EMDN)

OPHTHALMOSCOPES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12120114
Trade Name
3.6V PROFESSIONAL OPHTH & LITHIUM CHARGER
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05055272701792
Basic UDI
50552727OPHTHALMOSCOPES39
Version Date
September 08, 2023
Manufacturer Last Update
July 01, 2021
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
131 Vinyals, Terrassa
Email
info@visiometrics.com
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:2008-04-25~None
Device Characteristics
Human Tissues
No
Animal Tissues
No