Ophthalmoscope
- Risk class
- Class I
- CND nomenclatures code
- Z12120114
- Trade name
- 3.6V PROFESSIONAL OPHTH & LITHIUM CHARGER
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 05055272701792
- Basic UDI
- 50552727OPHTHALMOSCOPES39
- Version date
- September 08, 2023
- Manufacturer last update
- July 01, 2021
- Active status
- Yes
- Manufacturer name
- Keeler Ltd
- Country
- United Kingdom (ex Northern Ireland)
- Country type
- NON_EU
- Address
- Clewer Hill Road Windsor
- regulatory@keeler.co.uk
- SRN
- ES-AR-000001559
- Country
- Spain
- Address
- 131 Vinyals, Terrassa
- info@visiometrics.com
- Competent authority
- Agencia Española 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
- Human tissues
- No
- Animal tissues
- No
OPHTHALMOSCOPES
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 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.