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FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette - EUDAMED Registration 06970895474245

Access comprehensive regulatory information for FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette 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 06970895474245 and manufactured by Jiangsu Mole Bioscience Co., LTD. in China.

This page provides complete registration details including trade name (FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette), 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.

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EUDAMED Official Data
IVD General
06970895474245
No
FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette
Trade Name: FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette
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Device Description (EMDN)

MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105070599
Trade Name
FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06970895474245
Basic UDI
B-06970895474245
Version Date
December 13, 2024
Manufacturer Last Update
October 12, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
G116 Building, No.805, Jiankang Avenue, Medical New&Hi-tech District, Taizhou, Jiangsu
Email
Jiajunling@molechina.com
Authorized Representative
SRN
ES-AR-000019366
Country
Spain
Address
CARRER DE TAPIOLES, 33, 2- 1 Barcelona
Email
rep@themedunion.com
Telephone
+34644173535
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
No
Animal Tissues
No