Pure Global

Metal and plastic spectacle frames without lenses - EUDAMED Registration 04582669028053

Access comprehensive regulatory information for Metal and plastic spectacle frames without lenses 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 04582669028053 and manufactured by EYEVAN Inc. in Japan.

This page provides complete registration details including trade name (EYEVAN), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
04582669028053
No
Metal and plastic spectacle frames without lenses
Trade Name: EYEVAN
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

PLASTIC SPECTACLE FRAMES WITHOUT LENSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q02100202
Trade Name
EYEVAN
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04582669028053
Basic UDI
458266902RXCMBMW
Version Date
November 22, 2024
Manufacturer Last Update
September 13, 2022
Active Status
No
Manufacturer
Manufacturer Name
EYEVAN Inc.
Country
Japan
Country Type
NON_EU
Address
1-15-33 Minami-Aoyama Minato-Ku
Email
m.yamagishi@eyevan.co.jp
Authorized Representative
SRN
FR-AR-000025678
Country
France
Address
41 Rue Boissy d'Anglas Pairs
Email
m.yamagishi@eyevan.co.jp
Telephone
+33 1 84 25 05 15
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No