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EUDAMED registration 06971922134095Yes

Pupilometer

CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTDClass IEU EUDAMEDTrade name: OPHTALMOLOGY INSTRUMENTS FOR EVALUATION AND DIAGNOSIS - OTHERS
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12120199
Trade name
OPHTALMOLOGY INSTRUMENTS FOR EVALUATION AND DIAGNOSIS - OTHERS
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06971922134095
Basic UDI
697192213400HW
Version date
July 26, 2022
Manufacturer last update
August 23, 2021
Active status
Yes
Manufacturer
Manufacturer name
CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD
Country
China
Country type
NON_EU
Address
5 5 DANLONG ROAD, NAN’AN DISTRICT CHONGQING
Email
sale@yeasn.com
Authorized representative
Name
Shanghai International Holding Corp. GmbH(Europe)
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Poland
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

About this record

Access comprehensive regulatory information for Pupilometer 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 06971922134095 and manufactured by CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD in China.

This page provides complete registration details including trade name (OPHTALMOLOGY INSTRUMENTS FOR EVALUATION AND DIAGNOSIS - OTHERS), 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.