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EUDAMED registration 08800064500049No

DeepDx Connect - Prostate

DeepBio MFIVD GeneralEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W02029092
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08800064500049
Basic UDI
B-08800064500049
Version date
April 04, 2024
Manufacturer last update
April 18, 2023
Active status
No
Manufacturer
Manufacturer name
DeepBio MF
Country
Republic of Korea
Country type
NON_EU
Address
197-5 Gurodong-ro, Gurogu, Seoul, Repubic of Korea 08380 Seoul
Email
qms@deepbio.co.kr
Authorized representative
Name
AR Experts B.V.
SRN
NL-AR-000023989
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
info@ar-experts.eu
Telephone
+31889951333
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Netherlands
Market available
Netherlands:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

About this record

Access comprehensive regulatory information for DeepDx Connect - Prostate in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 08800064500049 and manufactured by DeepBio MF in Republic of Korea.

This page provides complete registration details including 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.