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EUDAMED registration D-K90508ZMNo

Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)

SHENZHEN REETOO BIOTECHNOLOGY CO., LTDIVD GeneralEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0105070503
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
D-K90508ZM
Basic UDI
B-K90508ZM
Version date
July 13, 2022
Manufacturer last update
August 16, 2021
Active status
No
Manufacturer
Manufacturer name
SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Country
China
Country type
NON_EU
Address
F406, Building F, Huafeng International Robot Industrial Park, Hangcheng Avenue, Nanchang Community, Xixiang Street, Bao'an District Not applicable Shenzhen
Email
service@reetoo.com.cn
Authorized representative
Name
Umedwings Netherlands B.V.
SRN
NL-AR-000000444
Country
Netherlands
Address
Treubstraat 1 Rijswijk
Email
ar@umedwings.eu
Telephone
+31 (0) 642758955
Regulatory information
Competent authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Italy
Device characteristics
Human tissues
No
Animal tissues
Yes
Device description (EMDN)

RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

About this record

Access comprehensive regulatory information for Influenza & SARS-CoV-2 Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay) 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 D-K90508ZM and manufactured by SHENZHEN REETOO BIOTECHNOLOGY CO., LTD in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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.