DREAMTECH VIETNAM CO., LTD

FDA Device Registration & Listing · Tu Son Bac Ninh, VN · Registration 3043479346

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043479346
FEI Number
3043479346
Entity Name
DREAMTECH VIETNAM CO., LTD
City/State/Country
Tu Son Bac Ninh, VN
Establishment Address
No.100, Huu Nghi Road, VSIP Bac Ninh, Tu Son Ward, Tu Son Bac Ninh 16353, VN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Dreamtech co., ltd. (Owner Number: 10058403)
Owner / Operator Contact Address
670 Daewangpangyo-ro, Bundang-gu, Seongnam-si, KR-41 13494, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cherish Serenity; CorVitals; LifeSignals Wireless Electrocardiogram Patch UbiqVue™ 2A Multi-parameter System (UX2550) Stealth System S300 LifeSignals Multi-parameter Remote Monitoring Platform Cardea 20/20 ECG; CardeaScreen; MedicECG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2020-10-21
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2020-10-21
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2018-09-16
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2018-09-16
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2018-09-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-11-20
DQA Oximeter Cardiovascular Class 2 870.2700 2024-11-20
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2024-11-20
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2024-11-20
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-02-02
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2021-02-02
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2021-07-23
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2021-07-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-07-23
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-04-15

Official Correspondent

Donghwan Kim

US Agent Details

Saravanan Balasubramanian Business: LifeSignals, Inc. Email: saravanan@lifesignals.com Phone: (510) 7706412

Related Public Records

Same Entity

Dreamtech co., ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014848734 DREAMTECH CO., LTD. Asan-si Chungnam, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K131913 Philips Medizin Systeme Boeblingen GmbH INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC 2013-11-26
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K832250 Litton Medical Electronics SERVOMED BASIC BEDSIDE UNIT SMA 102- 1984-06-01
K801515 Abbott Medical Electronics Co. ABBY II PATIENT MONITOR OR VITAL SIGNS M 1980-07-08
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11

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

Registration Number Establishment Name Location
3033118181 CHERO TECHNOLOGY CO., LTD. Jiaxing Zhejiang, CN
3026960443 Cicor Medtec Bucharest Bucharest Bucuresti, RO
3038761440 Corsano Health SA Plan-les-Ouates Geneve, CH
3016595211 DYNAMIC EMS LTD Dalgety Bay Fife, GB
3012302888 QUIPMENT INC. Kennesaw, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043479346. Last updated year: 2026. Please use registration number 3043479346 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.