Pure Global AI
EUDAMED registration 06977987930009No

Spectacle Frames

Hangzhou Wohu Optical Co., Ltd.Class IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q02100201
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06977987930009
Basic UDI
697798793WHSF01BY
Active status
No
Manufacturer
Manufacturer name
Hangzhou Wohu Optical Co., Ltd.
Country
China
Country type
NON_EU
Address
No.108 Shixin Rd, Hangzhou, Zhejiang
Email
250628747@qq.com
Authorized representative
Name
SUNGO Europe B.V.
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
Device description (EMDN)

METAL SPECTACLE FRAMES WITHOUT LENSES

About this record

Access comprehensive regulatory information for Spectacle 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 06977987930009 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.