Pure Global AI
EUDAMED registration 06971042225154No

8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit

SHANGHAI ZJ BIO-TECH CO., LTDIVD GeneralEU EUDAMEDTrade name: 8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0103080105
Trade name
8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06971042225154
Basic UDI
B-06971042225154
Version date
October 18, 2024
Manufacturer last update
September 01, 2022
Active status
No
Manufacturer
Manufacturer name
SHANGHAI ZJ BIO-TECH CO., LTD
Country
China
Country type
NON_EU
Address
528 Ruiqing Road No. 20 and 21 Building, 528 Ruiqing Road, Zhangjiang High-tech Industrial East District Shanghai
Email
registration@liferiver.com.cn
Authorized representative
Name
RIOMAVIX SOCIEDAD LIMITADA
SRN
ES-AR-000001202
Country
Spain
Address
55 Calle de Almansa Madrid
Email
leis@riomavix.com
Regulatory information
Competent authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&T-CELL TYPING)

About this record

Access comprehensive regulatory information for 8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06971042225154 and manufactured by SHANGHAI ZJ BIO-TECH CO., LTD in China.

This page provides complete registration details including trade name (8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit), manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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.