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EUDAMED registration 00816784020178No

ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000

LGC Clinical Diagnostics, Inc.IVD Annex II List BEU EUDAMEDTrade name: ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD Annex II List B
CND nomenclatures code
W0105080899
Trade name
ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00816784020178
Basic UDI
B-00816784020178
Version date
July 26, 2023
Manufacturer last update
July 24, 2023
Active status
No
Manufacturer
Manufacturer name
LGC Clinical Diagnostics, Inc.
Country
United States
Country type
NON_EU
Address
37 Birch Street Milford
Email
alexander.potter@lgcgroup.com
Authorized representative
Name
MEDIMARK EUROPE
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 Sécurité du Médicament et des Produits de Santé
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
Device description (EMDN)

CONTROLS - INF. IMMUNOLOGY - OTHER

About this record

Access comprehensive regulatory information for ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 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 00816784020178 and manufactured by LGC Clinical Diagnostics, Inc. in United States.

This page provides complete registration details including trade name (ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), 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.