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MAHE MEDICAL USA

USA · Laramie
✓ 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
76listed device types
Class I 56Class II 20Class III 0
plus 69 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
19registered devices
Class I 17Class II 2
27 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
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 States69 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil19 confirmed, 0 excluded
Manufacturer names merged into this page: MAHE MEDICAL USA · MAHE MEDICAL GMBH
Same-named companies — This database also contains companies with near-identical names: Mahe Medical GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Laramie

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

22011 · K110655

FDA listed device types

showing 8 of 76
Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Screw, Fixation, Bone 1Laparoscope, Gynecologic (And Accessories) 1Washer, Bolt Nut 1

Registration details (sample)

MarketIdentifierNameClass / date
USK110655MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM2011-10-27
USK102845MAHE FIXATION PLATE AND SCREW SYSTEM2011-05-13
BR80003890109Instrumental para Sistema de Fixação Cervical MaheClass I
BR10314809016KIT DE LAVAGEM MAHEMEDICALClass II
BR80003890110Instrumental para Sistema de Fixação Toracolombar MaheClass I

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