EUDAMED registration 00850041090047No

ACCURUN Babesia Molecular Controls Kit

Name: ACCURUN Babesia Molecular Controls Kit — EUDAMED registration 00850041090047
Creator: LGC Clinical Diagnostics, Inc.
Keywords: ACCURUN Babesia Molecular Controls Kit, 00850041090047, ACCURUN Babesia Molecular Controls Kit, Class B, LGC Clinical Diagnostics, Inc., EUDAMED registration

LGC Clinical Diagnostics, Inc.Class BEU EUDAMEDTrade name: ACCURUN Babesia Molecular Controls Kit

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class B
CND nomenclatures code: W0105080805
Trade name: ACCURUN Babesia Molecular Controls Kit
Implantable: No
Reusable: No
Measuring function: No

Registration information

Primary DI: 00850041090047
Basic UDI: 0816784020062XX
Version date: October 20, 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: IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market: Ireland
Market available: Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None

Device characteristics

Human tissues: Yes
Animal tissues: No

Device description (EMDN)

PARASITOLOGY CONTROLS - INF.IMM.

About this record

Access comprehensive regulatory information for ACCURUN Babesia Molecular Controls Kit in the European Union medical device market through Pure Global AI's free database. This Class B device is registered with EU EUDAMED under Primary DI 00850041090047 and manufactured by LGC Clinical Diagnostics, Inc. in United States.

This page provides complete registration details including trade name (ACCURUN Babesia Molecular Controls Kit), 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.