Pure Global

Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing) - EUDAMED Registration 06928103000410

Access comprehensive regulatory information for Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing) in the European Union medical device market through Pure Global AI's free database. This IVD Annex II List A device is registered with EU EUDAMED under Primary DI 06928103000410 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
IVD Annex II List A
06928103000410
No
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

HEPATITIS B VIRUS - NA REAGENTS

Device Classification
Risk Class
IVD Annex II List A
CND Nomenclatures Code
W0105020216
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06928103000410
Basic UDI
B-06928103000410
Version Date
January 03, 2023
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
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Slovakia
Device Characteristics
Human Tissues
Yes
Animal Tissues
No