HomeUSALaboratoires Urgo S.A.

Laboratoires Urgo S.A.

USA · St Louis
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
4listed device types
Class I 3Class II 0Class III 0unclassified 1
plus 7 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
10 including historic records
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
9active device licences
Class II 9
23 including historic records
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 States7 registration records, 8 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 0 excluded
Saudi Arabia7 confirmed, 0 excluded
Canada9 confirmed, 2 excluded
Manufacturer names merged into this page: LABORATOIRES URGO · URGO LABORATOIRES
Same-named companies — This database also contains companies with near-identical names: LABORATOIRES URGO, URGO LABORATOIRES. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
St Louis

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

11997
11998
12006
12007
22010
12013
12015

FDA listed device types

Dressing, Wound, Hydrophilic 1Bandage, Elastic 1Dressing, Wound, Occlusive 1Dressing, Wound, Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
USK143017Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver2015-08-07
USK123219URGOCLEAN ABSORBENT WOUND DRESSING2013-03-18
USK100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER2010-06-11
BR80246910036URGO K2 LÁTEX FREEClass I
BR80246910072URGO K1Class I
SAME0000009703SFDAA00001Urgopore
SAME0000009703SFDAA00002Urgofilm
CA77017CELLOSORB NON ADHESIVEClass II
CA77019CELLOSORB ADHESIVEClass II
CA77021URGOTULClass II

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