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Home›STREIFENEDER ORHTO.PRODUCTION

STREIFENEDER ORHTO.PRODUCTION

✓ 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
14listed device types
Class I 14Class II 0Class III 0
plus 14 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
43registered 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 States14 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia43 confirmed, 0 excluded
Manufacturer names merged into this page: STREIFENEDER ortho.production gmbH · STREIFENEDER ORTHO. PRODUCTION GMBH · Streifeneder ortho production GmbH · Streifeneder ortho.production GmbH · Streifeneder Ortho. Production GmbH · STREIFENEDER ORHTO.PRODUCTION
Same-named companies — This database also contains companies with near-identical names: STREIFENEDER ORTHO. PRODUCTION GMBH. 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 14
Orthosis, Corrective Shoe 1Sling, Arm, Overhead Supported 1Orthosis, Limb Brace 1Joint, Knee, External Brace 1Orthosis, Lumbar 1Prosthesis, Thigh Socket, External Component 1Component, External, Limb, Ankle/Foot 1Joint, Knee, External Limb Component 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80018110084FAMÍLIA DE COMPONENTES DE PRÓTESE EXTERNA DE MEMBROS INFERIORES STREIFClass I
SAME0000007909SFDAA00001PediSupport night—
SAME0000007909SFDAA00005Tube Clamp Adapter—

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