Htl Strefa S A

FDA Filings

This page includes the latest FDA filings for Htl Strefa S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006142663
FEI Number3006142663
NameHTL-STREFA, INC.
Owner & OperatorHTL-STREFA S.A.
Contact AddressADAMOWEK 7 --
OZORKOW PL-NOTA 95-035 PL
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3005 Chastain Meadows Pkwy Ste 300
MARIETTA, GA 30066 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number9613304
FEI Number3004034544
NameHTL-STREFA S.A.
Owner & OperatorHTL-STREFA S.A.
Contact AddressADAMOWEK 7 --
OZORKOW PL-NOTA 95-035 PL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressADAMOWEK 7
OZORKOW Lodzkie, 95-035 PL
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
HTL STREFA S A
 LEADER, pen needles 88972024-01-25
HTL STREFA S A
 LEADER, pen needles 88982024-01-25
HTL STREFA S A
 DropSafe™ Inject-Safe Barrier Bandage™ 60702023-07-03
HTL STREFA S A
 ProAdvantage, safety lancets 77032023-04-06
HTL STREFA S A
 ProAdvantage, safety lancets 77022023-04-06
HTL STREFA S A
 ProAdvantage, safety lancets 77012023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96632023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96622023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96612023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96602023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96592023-04-06
HTL STREFA S A
 Safe-T-Lance Plus, safety lancets 96582023-04-06
HTL STREFA S A
 MiniCollect Lancelino, safety lancets 90962022-11-23
HTL STREFA S A
 MiniCollect Lancelino, safety lancets 90952022-11-23
HTL STREFA S A
 MiniCollect Lancelino, safety lancets 90942022-11-23
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96352022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96432022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96422022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96412022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96402022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96392022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96382022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96372022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96362022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96342022-11-16
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96332022-11-16
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96502022-11-14
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96552022-11-14
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96542022-11-14
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96532022-11-14
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96522022-11-14
HTL STREFA S A
 DropSafe ergoLance, safety lancets 96512022-11-14
HTL STREFA S A
 DropSafe Haemolance Plus, safety lancets 96322022-11-14
HTL STREFA S A
 DropSafe Prolance, safety lancets 96492022-11-11
HTL STREFA S A
 DropSafe Prolance, safety lancets 96482022-11-11
HTL STREFA S A
 DropSafe Prolance, safety lancets 96472022-11-11
HTL STREFA S A
 DropSafe Prolance, safety lancets 96462022-11-11
HTL STREFA S A
 DropSafe Prolance, safety lancets 96452022-11-11
HTL STREFA S A
 Droplet Medlance Plus, safety lancets 96312022-11-08
HTL STREFA S A
 DropSafe Prolance, safety lancets 96442022-11-08
HTL STREFA S A
 Droplet Acti-Lance, safety lancets 96302022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96792022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96782022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96772022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96762022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96752022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96742022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96732022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96722022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96712022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96702022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96692022-11-08
HTL STREFA S A
 DropSafe MediSafe Solo, safety lancets 96572022-11-08
HTL STREFA S A
 DropSafe MediSafe Solo, safety lancets 96562022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96682022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96672022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96662022-11-08
HTL STREFA S A
 DropSafe Medlance Plus, safety lancets 96652022-11-08
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96892022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96862022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96942022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96932022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96922022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96912022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96902022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96882022-11-03
HTL STREFA S A
 DropSafe Acti-Lance, safety lancets 96872022-11-03
HTL STREFA S A
 DropSafe, safety pen needles 84322022-10-06
HTL STREFA S A
 DropSafe, safety pen needles 87972022-10-06
HTL STREFA S A
 DropSafe, safety pen needles 84332022-10-06
HTL-Strefa S.A.
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 Lan2022-07-08
HTL STREFA SA
DropSafe Safety Pen Needles2022-01-07
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60752021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60832021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60822021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60812021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60802021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60792021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60782021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60772021-12-22
HTL STREFA S A
 DropSafe® Insulin Safety Syringe with Fixed Needle 60762021-12-22
HTL STREFA S A
 DropSafe, safety pen needles 81612021-10-26
HTL STREFA S A
 droplet Genteel lancing device 91502021-10-01
HTL STREFA S A
 DropSafe Safety Needle LD 60692021-09-14
HTL STREFA S A
 DropSafe Safety Needle LD 60682021-09-14
HTL STREFA S A
 DropSafe Syringe with Safety Needle 60732021-09-14
HTL STREFA S A
 DropSafe Syringe with Safety Needle 60722021-09-14
HTL STREFA S A
 Medlance, safety lancet 70072021-08-20
HTL STREFA S A
 Medlance, safety lancet 70062021-08-12
HTL STREFA S A
 Medlance, safety lancet 70052021-08-12
HTL STREFA S A
 Medlance, safety lancet 70042021-08-12
HTL STREFA S A
 Medlance, safety lancet 70032021-08-12
HTL STREFA S A
 Medlance, safety lancet 70022021-08-12
HTL STREFA S A
 Medlance, safety lancet 70012021-08-12
HTL STREFA S A
 Haemolance Plus, safety lancet 73672021-06-14
HTL STREFA S A
 Haemolance Plus, safety lancet 73662021-06-14
HTL STREFA S A
 Acti-Lance, safety lancet 73122021-06-14
HTL STREFA S A
 Acti-Lance, safety lancet 73112021-06-14
HTL STREFA S A
 Acti-Lance, safety lancet 73132021-06-14
HTL STREFA S A
 droplet®, pen needles 74972020-12-01
HTL STREFA S A
 droplet®, pen needles 74962020-12-01
HTL STREFA S A
 droplet®, pen needles 74982020-12-01
HTL-Strefa S.A.
Droplet Pen Needle 30G & 33G2020-10-15
HTL-Strefa S.A
Droplet Pen Needle 34G2020-04-21
HTL-STREFA, INC. [HTL-STREFA S.A.]
droplet pen needle2018-03-28
HTL-STREFA S.A.
droplet pen needle2018-03-28
HTL-STREFA S.A.
DROPLET PEN NEEDLE2018-03-21
HTL-STREFA, INC. [HTL-STREFA S.A.]
DropSafe Safety Pen Needle2017-12-20
HTL-STREFA S.A.
DropSafe Safety Pen Needle2017-12-20
HTL-Strefa S.A.
DropSafe Safety Pen Needle2017-12-12
HTL-STREFA, INC. [HTL-STREFA S.A.]
droplet pen needle2015-07-08
HTL-STREFA S.A.
droplet pen needle2015-07-08
HTL-STREFA S.A.
Droplet Pen Needles2015-06-25
HTL-STREFA, INC. [HTL-STREFA S.A.]
ergoLance1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
droplet personal lancets1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
droplet lancing device1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
Safe-T-Lance Plus1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
PROLANCE1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
MediSafe SOLO1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
MEDLANCE1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
MEDLANCE plus1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
HaemoFine1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
HAEMOLANCE1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
HAEMOLANCE Plus1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
Acti-Lance1996-10-31
HTL-STREFA, INC. [HTL-STREFA S.A.]
Acti-Lance baby1996-10-31
HTL-STREFA S.A.
ergoLance1996-10-31
HTL-STREFA S.A.
droplet personal lancets1996-10-31
HTL-STREFA S.A.
droplet lancing device1996-10-31
HTL-STREFA S.A.
Safe-T-Lance Plus1996-10-31
HTL-STREFA S.A.
PROLANCE1996-10-31
HTL-STREFA S.A.
MediSafe SOLO1996-10-31
HTL-STREFA S.A.
MEDLANCE1996-10-31
HTL-STREFA S.A.
MEDLANCE plus1996-10-31
HTL-STREFA S.A.
HaemoFine1996-10-31
HTL-STREFA S.A.
HAEMOLANCE1996-10-31
HTL-STREFA S.A.
HAEMOLANCE Plus1996-10-31
HTL-STREFA S.A.
Acti-Lance1996-10-31
HTL-STREFA S.A.
Acti-Lance baby1996-10-31

Related Finance Registrations
NCAGE Code0873HHTL-STREFA S.A.
CAGE Code0873HHTL-STREFA S.A.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009293355Ningpo ,China (Mainland) -> Savannah, GeorgiaINSULIN SYRINGE4600 CTN
202009293355Ningpo ,China (Mainland) -> Savannah, GeorgiaINSULIN SYRINGE4600 CTN
202009293355Ningpo ,China (Mainland) -> Savannah, GeorgiaINSULIN SYRINGE4600 CTN
2020092289531Gdynia,Poland -> Savannah, GeorgiaMEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-133 INVOICE VAT NO.: (S)FSE-488 20 EX HS-CODE : 90 18 3942 PKG
2020092289531Gdynia,Poland -> Savannah, GeorgiaMEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-133; 2020-154 INVOICE VAT NO.: (S)FSE-485 20 EX HS-CODE : 90 18 3942 PKG
202009199974Stadersand,Federal Republic of Germany -> New Orleans, LouisianaSAFE-T LANCE HS#9018396 PCL
2020091772896Gdynia,Poland -> Philadelphia, Pennsylvania21 PACKAGES MEDICAL EQUIPMENT KGM MTQ LANCETS FOR DIABETICS P.O.: 2020-165 INVOICE VAT NO.: (S)FSE-465 20 EX21 PKG
2020091664961Gdynia,Poland -> New York/Newark Area, Newark, New JerseyLANCETS FOR DIABETICS MEDICAL EQUIPMENT P.O.: 2020-164 INVOICE VAT NO.: (S)FSE-490 20 EX HS-CODE : 90 18 3910 PKG
2020091664938Gdynia,Poland -> New York/Newark Area, Newark, New JerseyLANCETS FOR DIABETICS MEDICAL EQUIPMENT P.O.: 2020-172; 2020-175 INVOICE VAT NO.: (S)FSE-489 20 EX HS: 9018390010 PKG
2020091664802Gdynia,Poland -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCT LANCETS FOR DIABETICS P.O.: 2020-161 4512881443 INVOICE VAT NO.: (S)FSE-491 20 EX HS-CODE : 90 18 3920 PKG
2020091245907Gdynia,Poland -> Philadelphia, PennsylvaniaMEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-165; 2020-166 INVOICE VAT NO.: (S)FSE-453 20 EX HS-CODE : 90 18 3942 PKG
2020091245907Gdynia,Poland -> Philadelphia, PennsylvaniaMEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-146; 2020-147; 2020-165 INVOICE VAT NO.: (S)FSE-452 20 EX HS-CODE : 90 18 3942 PKG
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