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Optical Frames - EUDAMED Registration 06976215590022

Access comprehensive regulatory information for Optical Frames 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 06976215590022 and manufactured by Wenzhou 101 Optical Co., Ltd. in China.

This page provides complete registration details including trade name (Optical Frames ), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf 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
06976215590022
No
Optical Frames
Trade Name: Optical Frames
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Device Description (EMDN)

METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q02100203
Trade Name
Optical Frames
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976215590022
Basic UDI
6976215590022BJ
Version Date
March 29, 2023
Manufacturer Last Update
March 23, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
4 Floor, Building 7, Ouhai High-tech Industrial Park, NO. 32 Fuhao Road, Guoxi Sub-district, Ouhai District Wenzhou, Zhejiang
Email
fred@101optical.com
Authorized Representative
SRN
DE-AR-000023447
Country
Germany
Address
8 GneisenaustraรŸe Dรผesseldorf
Email
eurep@humiss.com
Telephone
+49-211-90760042
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Market Available
Italy:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No