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HemosIL Factor Diluent - EUDAMED Registration 08426950062295

Access comprehensive regulatory information for HemosIL Factor Diluent in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 08426950062295 and manufactured by Instrumentation Laboratory Company in United States.

This page provides complete registration details including trade name (HemosIL Factor Diluent), 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 A
08426950062295
No
HemosIL Factor Diluent
Trade Name: HemosIL Factor Diluent
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Device Description (EMDN)

COAGULOMETERS - CONSUMABLES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0202020185
Trade Name
HemosIL Factor Diluent
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08426950062295
Basic UDI
84269500622956R
Version Date
September 11, 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:2024-09-01~None, Belgium:2024-09-01~None, Bulgaria:2024-09-01~None, Croatia:2024-09-01~None, Cyprus:2024-09-01~None, Czechia:2024-09-01~None, Denmark:2024-09-01~None, Estonia:2024-09-01~None, Finland:2024-09-01~None, France:2024-09-01~None, Germany:2024-09-01~None, Greece:2024-09-01~None, Hungary:2024-09-01~None, Iceland:2024-09-01~None, Ireland:2024-09-01~None, Italy:2024-09-01~None, Latvia:2024-09-01~None, Liechtenstein:2024-09-01~None, Lithuania:2024-09-01~None, Luxembourg:2024-09-01~None, Malta:2024-09-01~None, Netherlands:2024-09-01~None, Norway:2024-09-01~None, Poland:2024-09-01~None, Portugal:2024-09-01~None, Romania:2024-09-01~None, Slovakia:2024-09-01~None, Slovenia:2024-09-01~None, Spain:2024-09-01~None, Sweden:2024-09-01~None, Tรผrkiye:2024-09-01~None, United Kingdom (Northern Ireland only):2024-09-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No