HomeUSAProbo Medical LLC

Probo Medical LLC

USA · Fishers IN · www.probomedical.com
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
0UDI-DI device records
USUnited StatesFDA openFDA
23listed device types
Class I 0Class II 23Class III 0
plus 53 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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 States53 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: Probo Medical Ltd · PROBO MEDICAL SAS · PROBO MEDICAL, INC.

Company information

Country
USA
City
Fishers IN
Website
www.probomedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsMagnetic Resonance Imaging – MRI (low-, high- and ultra-high-field)

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 23
Cystoscope And Accessories, Flexible/Rigid 1System, X-Ray, Mobile 1Biopsy Needle Guide Kit 1System, X-Ray, Tomography, Computed 1System, Nuclear Magnetic Resonance Spectroscopic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1Coil, Magnetic Resonance, Specialty 1Automated Radiological Image Processing Software 1

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