Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015946733

FEI Number

3015946733

Entity Name

NU EYNE CO., LTD.

City/State/Country

Guro-gu Seoul, KR

Establishment Address

#608, 28, Digital-ro 30-gil, Guro-gu Seoul 08389, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nu Eyne Co., Ltd. (Owner Number: 10078817)

Owner / Operator Contact Address

#608, 28, Digital-ro 30-gil, Guro-gu, KR-11 08389, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213629

PMA Number

N/A

All Registered Proprietary Names

ELEXIR 2 (Model: ALLIVE3) ELEXIR Electrode (Model: PS-2HP2) ADDNOX Electrode (Model: PS-2HP2) ADDNOX (Model: BPSPM1) Smile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2024-12-10
QGL	Transcutaneous Nerve Stimulator For Adhd	Neurology	Class 2	882.5898	2025-02-02
QGL	Transcutaneous Nerve Stimulator For Adhd	Neurology	Class 2	882.5898	2023-02-13

Official Correspondent

Dohyoung Kim

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

Nu Eyne Co., Ltd.

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

View Entity Profile →

Similar Registrations

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3010188009	CEFALY TECHNOLOGY	Liege, BE
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015946733. Last updated year: 2026. Please use registration number 3015946733 when referencing this establishment in official correspondence.