Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003591740

FEI Number

3003591740

Entity Name

MEDIANA CO., LTD.

City/State/Country

Wonju-Si, Gangwon-do, KR

Establishment Address

132, Donghwagongdan-ro, Munmak-eup, Wonju-Si, Gangwon-do 26365, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDIANA CO., LTD. (Owner Number: 9048468)

Owner / Operator Contact Address

132, Donghwagongdan-ro, Munmak-eup, Wonju-Si, Gangwon-do, KR-NOTA 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VITAL SIGNS MONITOR S207 MODEL HBP-2070 MULTIPLE NAMES USED N-560 I20,I30, I25, I35, I50, I55 Body Composition Analyzer Diagnostic Ultrasuond System Lucon M-series (M20, M30) Patient Monitor Nellcor Bedside SpO2 Patient Monitoring System (PM100N) V10 AVSM2 AVSM i BP S510 Colin Press Mate Insight-One Insight-I PATIENT MONITOR,YM6000 YM1000 AVM-1 VITAL SIGNS MONITOR ARGUS VCM SERIES HBP-T105 DT-100 Insight-micro+ Model 91220

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-08-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-08-16
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-08-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-08-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2005-08-15
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2019-10-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-06-29
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-07-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-03-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-01-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-01-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-01-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-03-28
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2009-03-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-03-28
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2009-03-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-03-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-03-28
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2016-10-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-01-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2005-08-15
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2011-10-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-06-29
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2016-10-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2010-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

MEDIANA CO., LTD.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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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9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003591740. Last updated year: 2026. Please use registration number 3003591740 when referencing this establishment in official correspondence.