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Ortho Pauher International Limited

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
17listed device types
Class I 17Class II 0Class III 0
plus 17 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
145registered devices
Class I 145
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States17 registration records, 0 510(k), 0 PMA
Brazil145 confirmed, 1 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: Ortho Pauher Ind. Com. E Dist. Ltda · ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA · Ortho Pauher International Limited · ORTHO PAUHER IND. COM. E DIST. LTDA. · Ortho Pauher lnd. Com . E Dist. LTDA
Same-named companies — This database also contains companies with near-identical names: ORTHO PAUHER IND. COM. E DIST. LTDA.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

showing 8 of 17
Orthosis, Corrective Shoe 1Bandage, Cast 1Cover, Limb 1Protector, Skin Pressure 1Cover, Cast 1Adaptor, Recreational 1Support, Patient Position 1Prosthesis, Breast, External, No Adhesive 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80223340092SANDÁLIA ORTOPÉDICA FLYFEET RELAXClass I
BR80223340021Familia de Almofadas Ortopédicas Ortho PauherClass I
BR80223340093SANDÁLIA ORTOPÉDICA FLY FEET NUVEMClass I
SAME0000005826SFDAA00001Freestanding Patient Positioner, Reusable—
SAME0000010982SFDAA00001External Silicone Breast Form—

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