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ALLIED MEDICAL, LLC

USA · Earth City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Australia — 4 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
62listed device types
Class I 36Class II 26Class III 0
plus 107 registration records and 11 510(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
55active device licences
Class II 47Class III 8
78 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 1IIa 5IIb 2
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 States107 registration records, 11 510(k), 0 PMA, 21 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada55 confirmed, 0 excluded
Manufacturer names merged into this page: Allied Medical LLC · ALLIED MEDICAL, LLC · ALLIED MEDICAL INSTRUMENTS INC.
Same-named companies — This database also contains companies with near-identical names: ALLIED MEDICAL INSTRUMENTS INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Earth City

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

11982
11987
11995
31996 · K955370
41997 · K971479
11998 · K982051

FDA listed device types

showing 8 of 62
Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Nebulizer (Direct Patient Interface) 1Bottle, Collection, Vacuum 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Ventilator, Continuous, Facility Use 1Oximeter 1Ventilator, Emergency, Powered (Resuscitator) 1Filter, Bacterial, Breathing-Circuit 1

Registration details (sample)

MarketIdentifierNameClass / date
USK982051KELOCATE SHEETING1998-08-05
USK971479DURALASTIC ANATOMICAL MALAR IMPLANTS1997-07-18
USK971481DURALASTIC ANATOMICAL NASAL IMPLANTS1997-07-18
CA1319SCHUCO - MISTClass II
CA3376ALLIED HEALTHCARE PRODUCTS INC ADAPTERClass II
CA3380ALLIED HEALTHCARE PRODUCTS INC ADAPTERClass II

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