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Home›USA›HTL-STREFA, INC.

HTL-STREFA, INC.

USA · Woodstock
✓ 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
8listed device types
Class I 1Class II 7Class III 0
plus 49 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
23registered devices
Class I 1Class II 22
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
0active device licences
16 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 States49 registration records, 8 510(k), 0 PMA
Brazil23 confirmed, 0 excluded
Manufacturer names merged into this page: HTL-STREFA S.A. · HTL-STREFA, INC. · HTL STREFA S.A · HTL STREFA SA
Same-named companies — This database also contains companies with near-identical names: HTL-STREFA S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Woodstock

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

12015 · K143437
12017 · K170988
12018 · K171982
22020 · K202340
22022 · K220643
12025 · K250016

FDA listed device types

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Syringe, Piston 1Syringe, Antistick 1Multiple Use Blood Lancet For Single Patient Use Only 1Needle, Hypodermic, Single Lumen 1Continuous Measurement Thermometer 1Tape And Bandage, Adhesive 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250016droplet® personal lancets2025-07-01
USK220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets2022-07-08
USK211716DropSafe Safety Pen Needles2022-01-07
BR80176560002Labfine pen needlesClass II
BR80176569001Haemolance Plus®Class II
BR80695719028DropletClass II

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