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ACCURUN Babesia Molecular Controls Kit - EUDAMED Registration 00850041090047

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 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
Class B
00850041090047
No
ACCURUN Babesia Molecular Controls Kit
Trade Name: ACCURUN Babesia Molecular Controls Kit
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Device Description (EMDN)

PARASITOLOGY CONTROLS - INF.IMM.

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
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
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