HomeIndiaSURETEX PROPHYLACTICS (INDIA) PVT LTD.

SURETEX PROPHYLACTICS (INDIA) PVT LTD.

India · Bangalore Karnataka
✓ 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
3listed device types
Class I 0Class II 3Class III 0
plus 12 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
13 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 States12 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: Suretex Prophylactics (India) Private Limited · SURETEX PROPHYLACTICS (INDIA) PVT LTD. · SURETEX PROPHYLACTICS (INDIA) LTD
Same-named companies — This database also contains companies with near-identical names: Suretex Prophylactics , Ltd., Suretex Prophylactics (India) Private Limited. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
India
City
Bangalore Karnataka

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

21998 · K983320
11999 · K992081
12000 · K000408

FDA listed device types

Condom, Synthetic 1Condom With Nonoxynol-9 1Condom 1

Registration details (sample)

MarketIdentifierNameClass / date
USK000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM2000-04-19
USK992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL1999-08-19
USK983320ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS1998-12-11

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