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Home›Sri Lanka›ANSELL SRI LANKA

ANSELL SRI LANKA

Sri Lanka · Malgama Malwana
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 15 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class II 5
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
3active device licences
Class II 3
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 States15 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil5 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: ANSELL LANKA (PVT.), LTD. · ANSELL SRI LANKA · ANSELL LANKA (PVT) LTD
Same-named companies — This database also contains companies with near-identical names: ANSELL LANKA (PVT.), LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Sri Lanka
City
Malgama Malwana

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

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Surgeon'S Gloves 1Accessory, Surgical Apparel 1Medical Glove, Specialty 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81496190008ENCORE LATEX ORTHOClass II
BR81496190009ENCORE LATEX MICROClass II
BR81496190001Encore Latex TexturedClass II
CA3351DERMAPRENE POWDER STERILE NEOPRENE SURGICAL GLOVESClass II
CA3375SENSI-DERM STERILE LATEX SURGICAL GLOVEClass II
CA11287GAMMEX BEIGE STERILE LATEX SURGICAL GLOVEClass II

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