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Optical Frame - EUDAMED Registration 06976289920435

Access comprehensive regulatory information for Optical Frame 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 06976289920435 and manufactured by WENZHOU NEWYEARN IMPORT&EXPORT CO.,LTD in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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
06976289920435
No
Optical Frame
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

SPECTACLE FRAMES WITHOUT LENSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q02100299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976289920435
Basic UDI
697628992000RA
Version Date
April 08, 2024
Manufacturer Last Update
March 14, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 304, building 1, Ruikang business building, Jinxiu Road, Nanhui street, Lucheng District, Wenzhou City
Email
sales01@newyearnoptical.com
Authorized Representative
SRN
DE-AR-000005110
Country
Germany
Address
1 Kochstr Willich
Email
info.m@luxuslw.de
Telephone
+49 1715605732
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Device Characteristics
Human Tissues
No
Animal Tissues
No