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Optical Lenses - EUDAMED Registration 06977987931006

Access comprehensive regulatory information for Optical 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 06977987931006 and manufactured by Hangzhou Wohu Optical Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06977987931006
No
Optical Lenses
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

MINERAL OPHTHALMIC LENSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q0210010299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977987931006
Basic UDI
697798793WHOL6F
Version Date
November 12, 2024
Manufacturer Last Update
October 25, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.108 Shixin Rd, Hangzhou, Zhejiang
Email
250628747@qq.com
Authorized Representative
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No