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Home›USA›Route 92 Medical, Inc.

Route 92 Medical, Inc.

USA · San Mateo
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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
3listed device types
Class I 0Class II 3Class III 0
plus 18 registration records and 14 510(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
0active device licences
9 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class III 7IIa 1
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 States18 registration records, 14 510(k), 0 PMA
Manufacturer names merged into this page: Route 92 Medical, Head Quarters · Route 92 Medical, West Jordan · ROUTE 92 MEDICAL, INC
Same-named companies — This database also contains companies with near-identical names: Route 92 Medical, West Jordan. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Mateo

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

22018
12019
42020
12021
12022
22023
22024
12025

FDA listed device types

Catheter, Percutaneous, Neurovasculature 1Catheter, Percutaneous 1Catheter, Thrombus Retriever 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set2025-05-19
USK2405298F Modified Sheath System2024-10-02
USK233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set2024-04-23

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