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HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls - EUDAMED Registration 08426950497028

Access comprehensive regulatory information for HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls 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 08426950497028 and manufactured by Instrumentation Laboratory Company in United States.

This page provides complete registration details including trade name (HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls), manufacturer information, authorized representative details, competent authority (Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico), 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
08426950497028
No
HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls
Trade Name: HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls
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Device Description (EMDN)

ANTI-B2-GLYCOPROTEIN I ANTIBODIES

Device Classification
Risk Class
Class B
CND Nomenclatures Code
W0102100503
Trade Name
HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM Controls
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08426950497028
Basic UDI
84269504970289Q
Version Date
July 29, 2024
Manufacturer Last Update
May 22, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
180 Hartwell Road Bedford
Email
Regulatory@werfen.com
Authorized Representative
SRN
IT-AR-000008169
Country
Italy
Address
338 Viale Monza Milano
Email
nbova@werfen.com
Regulatory Information
Competent Authority
Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Market Available
Austria:2024-06-24~None, Belgium:2024-06-24~None, Bulgaria:2024-06-24~None, Croatia:2024-06-24~None, Cyprus:2024-06-24~None, Czechia:2024-06-24~None, Denmark:2024-06-24~None, Finland:2024-06-24~None, France:2024-06-24~None, Germany:2024-06-24~None, Greece:2024-06-24~None, Hungary:2024-06-24~None, Iceland:2024-06-24~None, Ireland:2024-06-24~None, Italy:2024-06-24~None, Latvia:2024-06-24~None, Liechtenstein:2024-06-24~None, Lithuania:2024-06-24~None, Luxembourg:2024-06-24~None, Malta:2024-06-24~None, Netherlands:2024-06-24~None, Norway:2024-06-24~None, Poland:2024-06-24~None, Portugal:2024-06-24~None, Romania:2024-06-24~None, Slovakia:2024-06-24~None, Slovenia:2024-06-24~None, Spain:2024-06-24~None, Sweden:2024-06-24~None, Türkiye:2024-06-24~None, United Kingdom (Northern Ireland only):2024-06-24~None
Device Characteristics
Human Tissues
No
Animal Tissues
Yes