HomeTaiwanScandinavian Health Limited

Scandinavian Health Limited

Taiwan · Taoyuan City
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, South Korea, Australia — 3 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
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.

United States3 registration records, 4 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: SCANDINAVIAN HEALTH LTD.

Company information

Country
Taiwan
City
Taoyuan City

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

11996 · K954729
12012 · K120191
12013 · K124026
12014 · K141384

FDA listed device types

Introducer, Syringe Needle 1Injector, Pen 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
USK141384WHISPERJECT AUTOINJECTOR2014-09-12
USK124026LOBSTER AUTO-INJECTOR2013-09-13
USK120191PUSH-ON NEEDLE 30GX8MM2012-05-23

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