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ClariCT.AI - EUDAMED Registration D-88000468CAI-066B3Z

Access comprehensive regulatory information for ClariCT.AI in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI D-88000468CAI-066B3Z and manufactured by ClariPi Inc. in Republic of Korea.

This page provides complete registration details including trade name (ClariCT.AI), 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.

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EUDAMED Official Data
Class IIa
D-88000468CAI-066B3Z
Yes
ClariCT.AI
Trade Name: ClariCT.AI
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Device Description (EMDN)

COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11030692
Trade Name
ClariCT.AI
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-88000468CAI-066B3Z
Basic UDI
B-88000468CAI-066B3Z
Version Date
December 22, 2022
Manufacturer Last Update
December 02, 2022
Active Status
Yes
Manufacturer
Manufacturer Name
ClariPi Inc.
Country
Republic of Korea
Country Type
NON_EU
Address
B-2~4F, 11, Ihwajang 1-gil, Jongro-gu Seoul
Email
kimhj3014@claripi.com
Authorized Representative
SRN
NL-AR-000000235
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
e.unk@certification-experts.com
Telephone
+31850073210
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
Poland:2020-05-04~2024-05-27
Device Characteristics
Human Tissues
No
Animal Tissues
No