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EUDAMED registration D-CNMF000016915YKAB6XYes

Handhold Auto Refractometer

Shenzhen CERTAINN Technology Co., Ltd.Class IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q0299
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
D-CNMF000016915YKAB6X
Basic UDI
B-CNMF000016915YKAB6X
Version date
March 24, 2023
Manufacturer last update
March 23, 2023
Active status
Yes
Manufacturer
Country
China
Country type
NON_EU
Address
Tangtou 1st Road L302,Bldg.2,Skyworth Innovation Valley,No.8 Tangtou 1st Road,Tangtou Community,Shiyan Subdistrict,Bao'an District, 518108 Shenzhen,PEOPLE'S REPUBLIC OF CHINA Shenzhen
Email
qms-engineer@moptim.cn
Authorized representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory information
Competent authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

OPHTHALMIC DEVICES - OTHER

About this record

Access comprehensive regulatory information for Handhold Auto Refractometer 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 D-CNMF000016915YKAB6X and manufactured by Shenzhen CERTAINN Technology Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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.