Pure Global

Monoclonal Mouse Anti-Human CD79a/PE, Clone HM47 - EUDAMED Registration 06974501891709

Access comprehensive regulatory information for Monoclonal Mouse Anti-Human CD79a/PE, Clone HM47 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 06974501891709 and manufactured by Agilent Biosciences (Hangzhou) Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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 General
06974501891709
No
Monoclonal Mouse Anti-Human CD79a/PE, Clone HM47
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

MONOCLONAL ANTIBODIES FOR CYTOPLASMATIC ANTIGENS - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0103080299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974501891709
Basic UDI
B-06974501891709
Version Date
July 22, 2022
Manufacturer Last Update
September 14, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 208 Zhenzhong Road Hangzhou
Email
tom.chen@agilent.com
Authorized Representative
SRN
XI-AR-000001836
Country
United Kingdom (Northern Ireland only)
Address
Enterprise Hub, NW Business Complex, Derry
Email
AuthRep@CE-marking.eu
Telephone
+44(33)33031126
Regulatory Information
Competent Authority
The Medicines and Healthcare Products Regulatory Agency
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Denmark
Device Characteristics
Human Tissues
No
Animal Tissues
No