Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033520545

FEI Number

3033520545

Entity Name

SEVEN POINT ONE

City/State/Country

Seoul, KR

Establishment Address

Suite #301, Seoul Bio Hyuksin Community Center, 18 Jongamro, Sungbukgu, Seoul 02796, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Seven Point One (Owner Number: 10091685)

Owner / Operator Contact Address

Suite #301, Seoul Bio Hyuksin Community Center, 18 Jongamro, Sungbukgu, Seoul, KR-NOTA 02796, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AlzWIN-MD-US-25

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTY	Computerized Cognitive Assessment Aid, Exempt	Neurology	Class 2	882.1470	2024-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Seven Point One

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033520545. Last updated year: 2026. Please use registration number 3033520545 when referencing this establishment in official correspondence.