Edgecare Inc.

Korea, Republic · Seoul · www.edgecare.co.kr

✓ Record-verifiedregistrations found in 6 marketsEU SRN KR-MF-000039973

This company has registrations in European Union, United States, United Kingdom, Taiwan, Singapore, Hong Kong — 6 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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.

European Union3 raw hits, 0 excluded, 3 confirmed

United States3 registration records, 3 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: EDGECARE INC.

Regulatory identity

EU manufacturer SRN: KR-MF-000039973
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: CMC Medical Devices LTD

FDA 510(k) clearances by year

12024 · K231677

22026 · K252337

FDA listed device types

Automated Radiological Image Processing Software 1Media, Coupling, Ultrasound 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809887550132	EdgeFlow UH10L	Class IIa
EU	08809887550125	EdgeFlow UH10S	Class IIa
EU	08809887550002	EdgeFlow UH10	Class IIa
UK	41501	Handheld Ultrasound Scanners	Class IIa
US	K252337	EdgeFlow Gel Pad	2026-04-24
US	K252237	EdgeFlow UW20	2026-04-17
US	K231677	EdgeFlow UH10	2024-03-06

Edgecare Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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