Pure Global AI
EUDAMED registration 06928103082102No

Fluorimetric Immunoassay Analyser

Daan Gene Co., Ltd.Class AEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02020501
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06928103082102
Basic UDI
69281030821XFY
Version date
January 12, 2024
Manufacturer last update
July 07, 2022
Active status
No
Manufacturer
Manufacturer name
Daan Gene Co., Ltd.
Country
China
Country type
NON_EU
Address
No. 19 Xiangshan Road, Science Park, High & New Technology Development District Guangzhou
Email
hj@daangene.com
Authorized representative
Name
Lotus NL B.V.
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Netherlands
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

HISTOLOGICAL SAMPLES ANALYSERS

About this record

Access comprehensive regulatory information for Fluorimetric Immunoassay Analyser in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06928103082102 and manufactured by Daan Gene 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.