HTL-STREFA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006142663	3006142663	HTL-STREFA, INC.	1	Y	2026-01-01	113 Towne Lake Pkwy Ste 120 Woodstock GA US 30188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
16789	1053511925	K250016	droplet® personal lancets	QRK	2025-07-01
16789	1413121579	K223353	DropSafeTM SicuraTM	FMI	2022-12-02
16789	1515738483	K220643	DropSafe 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 Lancets	FMK	2022-07-08
16789	1460953173	K211716	DropSafe Safety Pen Needles	FMI	2022-01-07
16789	1328143941	K203792	Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle	FMI	2023-01-20
16789	1110377842	K202340	Droplet Pen Needle 30G & 33G	FMI	2020-10-15
16789	1943824663	K201044	CHIRANA Insulin Syringes	FMF	2022-01-18
16789	2040633960	K192082	Droplet Pen Needle 34G	FMI	2020-04-21
16789	1043435072	K180385	Infrared Body Thermometer	FLL	2018-05-11
16789	1791873409	K171984	Clickfine Pen Needle, Penfine Classic Pen Needle	FMI	2017-10-11
16789	1531031689	K171982	DROPLET PEN NEEDLE	FMI	2018-03-21
16789	1315484888	K170988	DropSafe Safety Pen Needle	FMI	2017-12-12
16789	1205623033	K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	MEG	2017-08-02
16789	2041925742	K153670	Genteel Lancing Device	FMK	2016-05-12
16789	1037161355	K153537	Sol-M Insulin Syringe, Sol-M TB Syringe	FMF	2016-06-17
16789	1155376086	K151311	Safe Block Pen Needle	FMI	2016-02-10
16789	1813709478	K143437	Droplet Pen Needles	FMI	2015-06-25
16789	1122403203	K132681	SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE	MEG	2014-05-22
16789	2040373648	K123684	SOL-CARE SAFETY NEEDLE	FMI	2013-05-08
16789	1568360164	K101359	INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)	FMF	2010-08-20
16789	1375537732	K052667	ARTSANA PISTON AND INSULIN SYRINGES	FMF	2005-11-25
16789	1997270204	K051783	ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES	FMI	2005-10-04
16789	1578123992
16789	1767127137