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Shanghai Xodus Medical Company Limited

China · Shanghai
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
30listed device types
Class I 24Class II 6Class III 0
plus 58 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
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 States58 registration records, 6 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia9 confirmed, 0 excluded
Manufacturer names merged into this page: XODUS MEDICAL, INC. · Shanghai Xodus Medical Company Limited · XODUS MEDICAL · Xodus Medical Inc.
Same-named companies — This database also contains companies with near-identical names: XODUS MEDICAL, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shanghai

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

22006 · K053321
12007 · K063587
12008 · K081647
12018 · K182080
12026 · K260903

FDA listed device types

showing 8 of 30
Stretcher, Hand-Carried 1Marker, Skin 1Label Or Tag, Sterile 1Handle, Scalpel 1Blade, Scalpel 1Scale, Surgical Sponge 1Device, Transfer, Patient, Manual 1Component, Traction, Non-Invasive 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260903Hot Pink Pad Warming System2026-04-16
USK182080Scope Antifogging System2018-09-19
USK081647ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS2008-08-12
BR10315990069SUPORTE EM GEL PARA ACOMODAÇÃO DE PACIENTEClass I
BR10315990070SUPORTE EM ESPUMA PARA ACOMODAÇÃO DE PACIENTEClass I
SAME0000005647SFDAA00004PinkProtect positioning kit for the ICU—
SAME0000005647SFDAA00010Small Armboard—

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