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Home›Mexico›DJ ORTHOPEDICS DE MEXICO

DJ ORTHOPEDICS DE MEXICO

Mexico
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
96listed device types
Class I 72Class II 24Class III 0
plus 135 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
26registered devices
Class I 25Class II 1
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
4active device licences
Class II 1Class III 3
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 States135 registration records, 6 510(k), 0 PMA, 3 excluded
Brazil26 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. · ALARON SURGICAL A DIVISION OF DJ ORTHOPEDICS, LLC · DJ ORTHOPEDICS DE MEXICO · DJ ORTHOPEDCS DE MEXICO S.A DE C.V · DJ ORTHOPEDICS .LLC
Same-named companies — This database also contains companies with near-identical names: Dj Orthopedics, LLC, DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Mexico

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

52001 · K011354
12002 · K021740

FDA listed device types

showing 8 of 96
Stimulator, Neuromuscular, External Functional 1Sleeve, Limb, Compressible 1Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Interferential Current Therapy 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Equipment, Traction, Powered 1Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat 1Pad, Heating, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK021740TOTAL KNEE CEMENTED, SEMI-CONSTRAINED2002-09-23
USK011354HIGH TIBIAL OSTEOTOMY PLATING SYSTEM2001-07-31
USK010594DJ ORTHOPEDICS POST SCREW2001-05-29
BR80676130019SUPORTE PARA JOELHOClass I
BR80676130022JOELHEIRA ARTICULADAClass I
BR10222460033ÓRTESE DE MEMBROS AIRCASTClass I
CA31177PROCART SYSTEMClass II
CA60154DURAFIX HAMSTRING ANCHOR, FEMORALClass III
CA60896OSTEOTRAC HTO DEVICEClass III

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