DREAMTECH CO., LTD.

FDA Device Registration & Listing · Asan-si Chungnam, KR · Registration 3014848734

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
3014848734
FEI Number
3014848734
Entity Name
DREAMTECH CO., LTD.
City/State/Country
Asan-si Chungnam, KR
Establishment Address
161, Asanbaelli-Ro 388 Beon-Gil, Eumbong-Myeon, Asan-si Chungnam 31408, KR
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

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2021-10-06
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2025-05-11
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
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2025-05-11
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
KQX Goniometer, Ac-Powered Orthopedic Class 1 888.1500 2021-08-10

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
3043479346 DREAMTECH VIETNAM CO., LTD Tu Son Bac Ninh, VN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K131913 Philips Medizin Systeme Boeblingen GmbH INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC 2013-11-26
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014848734. Last updated year: 2026. Please use registration number 3014848734 when referencing this establishment in official correspondence.
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