HomeSri LankaQUALITY LATEX PRODUCTS (PVT) Ltd.

QUALITY LATEX PRODUCTS (PVT) Ltd.

Sri Lanka · Hanwella Western
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia — 5 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 5Class II 0Class III 0
plus 5 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
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 States5 registration records, 3 510(k), 0 PMA, 60 excluded
Brazil1 confirmed, 7 excluded
Saudi Arabia1 confirmed, 5 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: QUALITY LATEX PRODUCTS (PVT) LTD · QUALITY LATEX PRODUCTS (PVT) Ltd. · Quality Latex Products (Pvt) Ltd.
Same-named companies — This database also contains companies with near-identical names: Quality Latex Corp. Sdn Bhd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Sri Lanka
City
Hanwella Western

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

11989 · K893075
11999 · K993271
12001 · K011995

FDA listed device types

Exerciser, Non-Measuring 1Tourniquet, Pneumatic 1Dam, Rubber 1Components, Exercise 1Tourniquet, Nonpneumatic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK011995POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)2001-07-31
USK993271QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS1999-12-02
USK893075PATIENT EXAMINATION GLOVES1989-11-07
BR10340440061Faixas Elásticas para ExercícioClass I
SAME0000021147SFDAA00001Resist A Band

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