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EUDAMED registration 00860008222404No

ASP System

ASP Health Inc.Class AEU EUDAMEDTrade name: ASP Device
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W0202059085
Trade name
ASP Device
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00860008222404
Basic UDI
08600082224ASPMK
Active status
No
Manufacturer
Manufacturer name
ASP Health Inc.
Country
United States
Country type
NON_EU
Address
500 Skokie Blvd Northbrook
Email
john.hart@asp-health.com
Authorized representative
SRN
NL-AR-000000111
Country
Netherlands
Address
13 Esdoornlaan Maarn
Email
office@cepartner4u.com
Telephone
+31343442524
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Italy
Device characteristics
Human tissues
Yes
Animal tissues
No
Device description (EMDN)

VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES

About this record

Access comprehensive regulatory information for ASP System 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 00860008222404 and manufactured by ASP Health Inc. in United States.

This page provides complete registration details including trade name (ASP Device), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.