HomeKorea, RepublicDAESUNG MAREF CO., LTD

DAESUNG MAREF CO., LTD

Korea, Republic · Gunpo-si · www.dsmaref.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN KR-MF-000008616

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 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
258UDI-DI device records
Class I 130Class IIa 128
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 3Class III 0
plus 20 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 3Class IIa 3
BRBrazilANVISA
7registered devices
Class I 4Class II 3
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
1 including historic records
TWTaiwanTFDA
9valid device licences
Class I 2Class II 7
SGSingaporeHSA SMDR
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 2IIa 4
HKHong KongMDACS
3valid listings
Class II 3
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union258 raw hits, 0 excluded, 258 confirmed
United States20 registration records, 14 510(k), 0 PMA, 1 excluded
United Kingdom6 confirmed, 0 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: DAESUNG MAREF CO.,LTD · DAESUNG MAREF CO.,LTD · DAESUNG MAREF CO., LTD. · DAESUNG MAREF CO., LTD

Regulatory identity

EU manufacturer SRN
KR-MF-000008616
EU authorised representative
KTR Europe GmbH
UK responsible person
Advena Ltd

Company information

Country
Korea, Republic
City
Gunpo-si
Website
www.dsmaref.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instrumentsOrthopaedics, Trauma & RehabilitationPhysiotherapy equipmentIntegrated Care, Rehabilitation & HomecareHomecare, long-term care & ageingConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12011
22012
12015
22016
12017
12020
52021
12023

FDA listed device types

Pack, Hot Or Cold, Water Circulating 1Sleeve, Limb, Compressible 1Massager, Powered Inflatable Tube 1Tourniquet, Pneumatic 1Exerciser, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08809315676526Class I
EU08809315676519Class I
EU08809315676502Class I
EU08809315676199Class I
UK32965Assist BandClass I
UK40485WRAPClass I
UK60707CTC-7Class IIa
USK231437LF9002023-07-19
USK202395SP-1000, SP-20002021-09-01
USK203498LX9max2021-07-02
BR10349310042Acessórios CTC-7Class I
BR10349310025PERNEIRAS REUTILIZAVEIS DOCTOR LIFE DVT - SERIESClass I
BR10349310023PERNEIRAS DOCTOR LIFE DVT SERIES DESCARTAVEISClass I

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