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CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold) - EUDAMED Registration 06935091671911

Access comprehensive regulatory information for CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold) in the European Union medical device market through Pure Global AI's free database. This IVD Annex II List B device is registered with EU EUDAMED under Primary DI 06935091671911 and manufactured by Qingdao Hightop Biotech Co., Ltd. in China.

This page provides complete registration details including trade name (CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)), 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 Annex II List B
06935091671911
No
CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)
Trade Name: CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)
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Device Description (EMDN)

CMV - RT & POC

Device Classification
Risk Class
IVD Annex II List B
CND Nomenclatures Code
W0105099001
Trade Name
CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06935091671911
Basic UDI
B-06935091671911
Version Date
February 17, 2025
Manufacturer Last Update
November 16, 2023
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
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No