MEDIANA Co., Ltd.

Korea, Republic · Gangwon-do · www.mediana-global.com

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

13listed device types

Class I 2Class II 10Class III 0unclassified 1

plus 20 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 1Class IIb 4

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class III 8Class IV 1

12 including historic records

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

5device registrations

CLASS B 2CLASS C 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1Class III 2IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 10 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: MEDIANA CO., LTD. · MEDIANA CO., LTD

Regulatory identity

UK responsible person: Advena Ltd

FDA 510(k) clearances by year

12005

12010

42011 · K112190

12016 · K152659

22017 · K170497

12020 · K200434

FDA listed device types

showing 8 of 13

Analyzer, Body Composition, Exempt 1System, Measurement, Blood-Pressure, Non-Invasive 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1System, Imaging, Pulsed Doppler, Ultrasonic 1Computer, Blood-Pressure 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	36022	Body Composition Analyser	Class IIa
UK	48049	AUTOMATED EXTERNAL DEFIBRILLATOR	Class IIb
UK	48047	AUTOMATED EXTERNAL DEFIBRILLATOR	Class IIb
US	K200434	V20, V20a, AVSM3 SNF	2020-10-09
US	K170497	V10	2017-12-15
US	K160358	DT-100	2017-02-24
BR	80443119004	Analisador de Composição Corporal MEDIANA	Class II
CA	84008	HBP-2070 NX PATIENT MONITOR	Class III
CA	84402	HBP-2070 NEXT PATIENT MONITOR	Class III
CA	87060	VITAL SIGNS MONITOR YM1000	Class III