HomeIsraelUrogen Pharma, Ltd.

Urogen Pharma, Ltd.

Israel · Ra'Anana Central
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 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
5listed device types
Class I 1Class II 4Class III 0
plus 5 registration records and 5 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States5 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: UROGEN PHARMA LTD.

Company information

Country
Israel
City
Ra'Anana Central

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.

Business registration

Legal name
UROGEN PHARMA LTD
Company number
513537621
Registration status
Active
Incorporated
2004-04-28

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22018 · K180354
12019 · K190987
12020 · K203321
12021 · K211032

FDA listed device types

Piston Syringe Lever 1Catheter, Coude 1Catheter Care Tray 1Catheter, Urological 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211032Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
USK203321Cystoject Syringe Lever2020-12-09
USK190987Uroject12 Syringe Lever2019-12-02

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