Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037341611

FEI Number

3037341611

Entity Name

LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED

City/State/Country

Hanoi Ha Noi, VN

Establishment Address

Lot 37-2.Quang Minh Industry Zone,Quang Minh Town,Me Linh District,Hanoi City,Vietnam, Hanoi Ha Noi 12907, VN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED (Owner Number: 10093181)

Owner / Operator Contact Address

Lot 37-2.Quang Minh Industry Zone,Quang Minh Town,Me Linh District,Hanoi City,Vietnam, Hanoi, VN-HN 12907, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243492

PMA Number

N/A

All Registered Proprietary Names

Model(S): UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP Ice Cooling IPL Hair Removal Device Model(S): M30U PR, M30U MW, M30U SG, M30U SK, M30U MP JMOON NouvelleSkin Facial Toning Device Pulse Oximeter Ulike Reglow Light Therapy Device, Model(S): UM10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-17
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-04-10
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2025-04-10
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-04-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-17
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-04-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-14
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2025-04-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-04-17
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2025-04-22
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-04-10
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-04-10

Official Correspondent

LIN YONGCHAO

US Agent Details

Leona Liu Business: AMERICA ULIKE E-COMMERCE CO., LTD. Email: blue@ulike.com Phone: (410) 3707635

Related Public Records

Same Entity

LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037341611. Last updated year: 2026. Please use registration number 3037341611 when referencing this establishment in official correspondence.