HomeNew ZealandSPEX LIMITED

SPEX LIMITED

New Zealand · Rolleston Canterbury
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
11registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
13active ARTG entries
Class I 13
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 States5 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia11 confirmed, 0 excluded
Manufacturer names merged into this page: Spex Ltd · SPEX LIMITED · SPEX Ltd

Company information

Country
New Zealand
City
Rolleston Canterbury

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

Support, Head And Trunk, Wheelchair 1Accessories, Wheelchair 1Cushion, Wheelchair 1Components, Wheelchair 1Board, Lap, Wheelchair 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80626470012Adequação postural - SpexClass I
SAME0000005121SFDAA00001Spex Thigh Support
SAME0000005118SFDAA00001Spex Medical Thigh Support

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