HomeUSAMedegen Medical Products

Medegen Medical Products

USA · Gallaway
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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
36listed device types
Class I 32Class II 4Class III 0
plus 37 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
9registered 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 States37 registration records, 0 510(k), 0 PMA, 4 excluded
Saudi Arabia9 confirmed, 0 excluded
Manufacturer names merged into this page: Medegen Medical Products

Company information

Country
USA
City
Gallaway

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 36
Cap, Surgical 1Container, Specimen, Sterile 1Device, Specimen Collection 1Dish, Tissue Culture 1Crutch 1Bedding, Disposable, Medical 1Stand, Infusion 1Bath, Sitz, Nonpowered 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000009070SFDAA00001Bag STB Non Sterile
SAME0000009073SFDAA00001Bag: WSB

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