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Reading Glasses - EUDAMED Registration 05060939041210

Access comprehensive regulatory information for Reading Glasses 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 05060939041210 and manufactured by Out of Site Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (eye-spec), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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
05060939041210
No
Reading Glasses
Trade Name: eye-spec
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Device Description (EMDN)

READY TO WEAR METAL SPECTACLES WITH MINERAL LENSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q0210030201
Trade Name
eye-spec
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060939041210
Basic UDI
506093904EYESPEC01GE
Active Status
No
Manufacturer
Manufacturer Name
Out of Site Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
1-3 High Street Great Dunmow
Email
contact@eye-spec.com
Authorized Representative
SRN
DK-AR-000039264
Country
Denmark
Address
4 Suomisvej Frederiksberg C
Email
info@sigmatechnordic.com
Regulatory Information
Competent Authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No