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Colorimeter Wave - EUDAMED Registration 15060970750000

Access comprehensive regulatory information for Colorimeter Wave 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 15060970750000 and manufactured by Cerium Visual Technologies Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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
15060970750000
No
Colorimeter Wave
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

OPHTHALMIC DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q0299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
15060970750000
Basic UDI
5060970750003WL
Active Status
No
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Appledore Road Tenterden
Email
claire@ceriumoptical.com
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Device Characteristics
Human Tissues
No
Animal Tissues
No