HUREV Co., Ltd.

Korea, Republic · Wonju-si Gangwondo · www.hurev.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN KR-MF-000008401

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 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

29UDI-DI device records

Class I 29

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 1Class IIb 3

BRBrazilANVISA

1registered devices

Class I 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

0active device licences

TWTaiwanTFDA

2valid device licences

Class II 1Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union29 raw hits, 0 excluded, 29 confirmed

United States1 registration records, 0 510(k), 0 PMA

United Kingdom4 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

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

Regulatory identity

EU manufacturer SRN: KR-MF-000008401
EU authorised representative: Obelis s.a.
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809868003565	—	Class I
EU	08809868003701	—	Class I
EU	08809868003657	—	Class I
EU	08809868003640	—	Class I
UK	11130	Defibrillation pads	Class IIb
UK	17554	Disposable EEG Electrode	Class I
UK	44771	Defibrillation pads	Class IIb
BR	80263400029	ELETRODO DESCARTÁVEL RMDESC	Class I

HUREV Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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