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ACCURUN 31 EBV IgM Positive Control - EUDAMED Registration 00816784020161

Access comprehensive regulatory information for ACCURUN 31 EBV IgM Positive Control 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 00816784020161 and manufactured by LGC Clinical Diagnostics, Inc. in United States.

This page provides complete registration details including trade name (ACCURUN 31 EBV IgM Positive Control), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00816784020161
No
ACCURUN 31 EBV IgM Positive Control
Trade Name: ACCURUN 31 EBV IgM Positive Control
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Device Description (EMDN)

OTHER VIROLOGY CONTROLS - INF.IMM.

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105080804
Trade Name
ACCURUN 31 EBV IgM Positive Control
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00816784020161
Basic UDI
B-00816784020161
Version Date
July 26, 2023
Manufacturer Last Update
July 24, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
37 Birch Street Milford
Email
alexander.potter@lgcgroup.com
Authorized Representative
SRN
FR-AR-000000182
Country
France
Address
11 RUE EMILE ZOLA BP 2332 GRENOBLE cedex 2
Email
info@medimark-europe.com
Telephone
+33 4 76 86 43 22
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Ireland
Device Characteristics
Human Tissues
Yes
Animal Tissues
No