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Strep A Antigen Rapid Test (Immunochromatography) - EUDAMED Registration 06935091672017

Access comprehensive regulatory information for Strep A Antigen Rapid Test (Immunochromatography) 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 06935091672017 and manufactured by Qingdao Hightop Biotech Co., Ltd. in China.

This page provides complete registration details including trade name (Strep A Antigen Rapid Test (Immunochromatography)), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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
06935091672017
No
Strep A Antigen Rapid Test (Immunochromatography)
Trade Name: Strep A Antigen Rapid Test (Immunochromatography)
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Device Description (EMDN)

STREP. A - RT & POC

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105090103
Trade Name
Strep A Antigen Rapid Test (Immunochromatography)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06935091672017
Basic UDI
B-06935091672017
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.369 Hedong Road Qingdao, Shandong
Email
registered@hightopqd.com
Authorized Representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Mรผnster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Croatia
Device Characteristics
Human Tissues
No
Animal Tissues
No