Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042204971

FEI Number

3042204971

Entity Name

AI.BLE Insight Co.,Ltd

City/State/Country

CHeonan Chungnam, KR

Establishment Address

33 Dokjeonggi-ro, Ipjang-myeon, Seobuk-gu, CHeonan Chungnam 31027, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AI.BLE Insight Co.,Ltd (Owner Number: 10094441)

Owner / Operator Contact Address

33 Dokjeonggiro-gil, Ipjang-myeon, Seobuk-gu, Cheonan, KR-44 31027, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MedNeuro3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2025-11-30

Official Correspondent

Chi Hyun Ahn

US Agent Details

Jongoh CHOO Business: SMGUSA LLC Email: ce@smgusa.org Phone: (307) 6502347

Related Public Records

Same Entity

AI.BLE Insight Co.,Ltd

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 3042204971. Last updated year: 2026. Please use registration number 3042204971 when referencing this establishment in official correspondence.