HomeUSAGENTELL LTDA

GENTELL LTDA

USA · Bristol
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
16listed device types
Class I 14Class II 0Class III 0unclassified 2
plus 22 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
4 including historic records
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 States22 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: GENTELL · GENTELL LTDA

Company information

Country
USA
City
Bristol

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

11999 · K990440

FDA listed device types

showing 8 of 16
Bag, Urinary, Ileostomy 1Gauze / Sponge,Nonresorbable For External Use 1Protector, Skin Pressure 1Bag, Urine Collecting, Ureterostomy 1Appliance, Colostomy, Disposable 1Protector, Ostomy 1Collector, Ostomy 1Cement, Stomal Appliance, Ostomy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK990440GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE1999-08-12

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