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HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM - EUDAMED Registration 08426950496984

Access comprehensive regulatory information for HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM 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 08426950496984 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), 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
08426950496984
No
HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM
Trade Name: HemosIL AcuStar Anti-ß2 Glycoprotein-I IgM
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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
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08426950496984
Basic UDI
8426950496984B8
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
Yes
Animal Tissues
Yes