Pure Global

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) - EUDAMED Registration 06971792050167

Access comprehensive regulatory information for Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) 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 06971792050167 and manufactured by Hangzhou Realy Tech 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
06971792050167
No
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

CORONAVIRUS

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105040619
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971792050167
Basic UDI
B-06971792050167
Version Date
July 21, 2022
Manufacturer Last Update
May 21, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
#2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District Hangzhou
Email
info@realytech.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.com
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
Germany
Market Available
Germany:2022-07-21~2027-07-21
Device Characteristics
Human Tissues
No
Animal Tissues
No