Data / Medical devices / Vietnam / Longcheer Meiko Electronics Vietnam Company Limited
Longcheer Meiko Electronics Vietnam Company Limited: FDA-registered device maker in Hanoi Ha Noi, Vietnam, 4 510(k) clearances
Longcheer Meiko Electronics Vietnam Company Limited is registered with the FDA (registration 3037341611) in Hanoi Ha Noi, Vietnam. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 26, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3037341611
- Address
- Lot 37-2.Quang Minh Industry Zone,Quang Minh Town,Me Linh District,Hanoi City,Vietnam, Hanoi Ha Noi, Vietnam, 12907
- Owner or operator
- LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED (10093181)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- April 10, 2025
- Registered through
- 2026
- Brand names listed
- Ice Cooling IPL Hair Removal Device, Ice Cooling IPL Hair Removal Device; Model(S): UI06S PR, UI06S PN, UI06S WH, JMOON NouvelleSkin Facial Toning Device, Model(S): M30U PR, M30U MW, M30U SG, M30U SK, M30U MP, Model(S): UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, Pulse Oximeter, 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, Ulike Reglow Light Therapy Device, Model(S): UM10
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Exporter to the US | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Contract manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Contract manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2025 | K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | OHT | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | accessdata.fda.gov |
| February 3, 2025 | K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | NFO | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | accessdata.fda.gov |
| January 10, 2025 | K243492 | Ulike Reglow Light Therapy Device (UM10) | OHS | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | accessdata.fda.gov |
| December 13, 2024 | K241998 | Ice Cooling IPL Hair Removal Device (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) | OHT | Substantially Equivalent | Shenzhen Ulike Smart Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Oximeter, Wellness
Updated March 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.