Eu Mdd Eu Md Class 2a On The Market 🇰🇷 South Korea

MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

NEUROPHET, Inc. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08800130400105
Basic UDI-DI Code
B-08800130400105
Reference
EN_NEUROPHET AQUA V1.0
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
NEUROPHET, Inc.

Additional Description

Neurophet AQUA is intended to automate the manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.

CND Nomenclature Codes

Code Description
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Certificates

Type Number
MDD Annex II (excluding section 4) CE-MDD-0124/03/2021/01

Available In Countries

🇬🇧 United Kingdom

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