HomeUSAAmg Medical Equipments, Inc.

Amg Medical Equipments, Inc.

USA · Elk Grove
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
20listed device types
Class I 13Class II 7Class III 0
plus 20 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
38active device licences
Class II 38
85 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 States20 registration records, 4 510(k), 0 PMA, 2 excluded
Canada38 confirmed, 1 excluded
Manufacturer names merged into this page: AMG MEDICAL INC.
Same-named companies — This database also contains companies with near-identical names: Amg Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Elk Grove

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

11989 · K884917
11990 · K902093
11994 · K940380
12006 · K052548

FDA listed device types

showing 8 of 20
Exerciser, Non-Measuring 1Attachment, Commode, Wheelchair 1Stethoscope, Manual 1Stand, Infusion 1Garment, Protective, For Incontinence 1Bedpan 1Adult Portable Bed Rails For Medical Purposes 1Adaptor, Hygiene 1

Registration details (sample)

MarketIdentifierNameClass / date
USK052548UROK ROCKING WHEELCHAIR, MODEL 700-4XX2006-01-06
USK940380AMG MED BRAND CLINICAL GLASS THERMOMETER1994-05-04
USK902093RESU-GARD CATHETER SUCTION1990-10-23
CA4642E-Z JECT LANCETSClass II
CA17655AMG DIGITAL THERMOMETER WITH BEEPERClass II
CA21397E-Z JECT INSULIN SYRINGESClass II

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