FDA Registration
Active
🇰🇷 South Korea
DREAMTECH CO., LTD.
Reg #: 3014848734
·
FEI: 3014848734
·
Expires 2026
Products
14
Proprietary Names
13
Establishment Types
3
Classifications
14
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Registration Details
- Registration Name
- DREAMTECH CO., LTD.
- Registration Number
- 3014848734
- FEI Number
- 3014848734
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 161, Asanbaelli-Ro 388 Beon-Gil, Eumbong-Myeon
- City
- Asan-si Chungnam
- Country
- KR
Owner / Operator
- Firm Name
- Dreamtech co., ltd.
- Operator Number
- 10058403
- Address
- 670 Daewangpangyo-ro, Bundang-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13494
- Country
- KR
- Correspondent
- Donghwan Kim
US Agent
- Business Name
- LifeSignals, Inc.
- Contact Name
- Saravanan Balasubramanian
- Address
- 426 S Hillview Dr
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
- [email protected]
- Phone
- 510 7706412 ext. 4
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2018-09-16 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-09-16 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2018-09-16 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-11-20 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-11-20 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2024-11-20 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2021-02-02 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2021-02-02 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2021-10-06 |
| Sterilizer, Chemical | MLR | Class 2 | General Hospital | No | 2025-05-11 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2024-04-15 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2020-10-21 |
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2021-08-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2025-06-23 |
Proprietary Names
Wireless Electrocardiogram Patch
UbiqVue 2A Multi-parameter System (UX2550)
Stealth System S300
DIGITSOLE PRO
STERLINK mini Sterilizer with STERLOAD mini Cassette
LifeSignals Multi-parameter Remote Monitoring Platform
Cardea 20/20 ECG; CardeaScreen; MedicECG
STERLINK plus Sterilizer with STERLOAD Cassette
Cherish Serenity; CorVitals; LifeSignals
MotionSense
STERLINK plus sterilizer with STERPACK plus cassette
ECG Assist Lite Plus
ECG Assist Lite
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device