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FOXXMED LTD.

Taiwan · Yilan County · www.foxxmed.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000022145

This company has registrations in European Union, United States, United Kingdom, Singapore, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
107UDI-DI device records
Class I 15Class IIa 92
USUnited StatesFDA openFDA
7listed device types
Class I 6Class II 1Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 2Class IIa 2
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
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union107 raw hits, 0 excluded, 107 confirmed
United States8 registration records, 0 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Manufacturer names merged into this page: FOXXMED LTD

Regulatory identity

EU manufacturer SRN
TW-MF-000022145
EU authorised representative
Obelis s.a.
UK responsible person
Eden Medical (UK) Limited

Company information

Country
Taiwan
City
Yilan County
Website
www.foxxmed.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, 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 listed device types

Strap, Head, Gas Mask 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Device, Fixation, Tracheal Tube 1Orthopedic Manual Surgical Instrument 1Bandage, Elastic 1Ventilator, Non-Continuous (Respirator) 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04719876362414—Class IIa
EU04719876362407—Class IIa
EU04719876362391—Class IIa
EU04719876361370Airgap High Flow Nasal Cannula XLClass IIa
UK34864Ories Cohesive BandageClass I
UK60882Chin StrapClass I
UK35201Foxxmed Adult High Flow Nasal CannulaClass IIa

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