HomeGermanyHG Medical GmbH

HG Medical GmbH

Germany · Raisting Bavaria
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
31listed device types
Class I 12Class II 19Class III 0
plus 169 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered 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 States169 registration records, 0 510(k), 0 PMA, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: HG MEDICAL USA, LLC · HG Medical GmbH · HG MEDICAL GMBH
Same-named companies — This database also contains companies with near-identical names: HG MEDICAL USA, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Raisting Bavaria

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 31
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Appliance, Fixation, Spinal Intervertebral Body 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Appliance, Fixation, Spinal Interlaminal 1Pin, Fixation, Smooth 1Appliance, Fixation, Nail/Blade/Plate Combination, Single Component 1

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