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 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 74992020-12-01
HTL STREFA S A
droplet®, pen needles 74982020-12-01
HTL STREFA S A
Micron, Droplet, pen needles 79202020-11-09
HTL STREFA S A
Micron, droplet, pen needles 79212020-11-09
HTL STREFA S A
MediSafe Solo, safety lancet 71302020-11-09
HTL STREFA S A
MediSafe Solo, safety lancet 71402020-11-09
HTL STREFA S A
DropSafe Syringe with Safety Needle 60532020-11-02
HTL STREFA S A
DropSafe Syringe with Safety Needle 60552020-11-02
HTL STREFA S A
DropSafe Syringe with Safety Needle 60542020-11-02
HTL-Strefa S.A.
Droplet Pen Needle 30G & 33G2020-10-15
HTL STREFA S A
Medlance, safety lancet 90132020-08-24
HTL STREFA S A
Medlance, safety lancet 90122020-08-24
HTL STREFA S A
Medlance, safety lancet 90082020-08-24
HTL STREFA S A
Medlance, safety lancet 90112020-08-24
HTL STREFA S A
Medlance, safety lancet 90102020-08-24
HTL STREFA S A
Medlance, safety lancet 90092020-08-24
HTL STREFA S A
ergoLance, safety lancet 85062020-07-08
HTL STREFA S A
ergoLance, safety lancet 85052020-07-08
HTL STREFA S A
ergoLance, safety lancet 85042020-07-08
HTL STREFA S A
ergoLance, safety lancet 84832020-07-08
HTL STREFA S A
ergoLance, safety lancet 84822020-07-08
HTL STREFA S A
ergoLance, safety lancet 84812020-07-08
HTL STREFA S A
Prolance, safety lancet 76202020-07-08
HTL STREFA S A
Prolance, safety lancet 76092020-07-08
HTL STREFA S A
Prolance, safety lancet 76042020-07-08
HTL STREFA S A
Prolance, safety lancet 76012020-07-08
HTL STREFA S A
Prolance, safety lancet 75992020-07-08
HTL STREFA S A
Prolance, safety lancet 75942020-07-08
HTL STREFA S A
Acti-Lance, safety lancet 71422020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 73232020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 73222020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 73212020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 71432020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 71412020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 71572020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 71562020-05-25
HTL STREFA S A
Acti-Lance, safety lancet 71552020-05-25
HTL-Strefa S.A
Droplet Pen Needle 34G2020-04-21
HTL STREFA S A
droplet® pen needles 83532020-04-03
HTL STREFA S A
droplet® pen needles 83522020-04-03
HTL STREFA S A
droplet® pen needles 83512020-04-03
HTL STREFA S A
droplet® pen needles 83502020-04-03
HTL STREFA S A
droplet® pen needles 83492020-04-03
HTL STREFA S A
droplet® pen needles 83482020-04-03
HTL STREFA S A
droplet® pen needle 83472020-04-03
HTL STREFA S A
droplet® pen needles 83452020-04-03
HTL STREFA S A
droplet® pen needles 83462020-04-03
HTL STREFA S A
Medlance Plus, safety lancet 72422020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 72412020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 72462020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 72452020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 72442020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 72432020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 70462020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 70452020-02-28
HTL STREFA S A
Medlance Plus, safety lancet 70442020-02-28
HTL STREFA S A
Medlance Plus safety lancet 70432020-02-28
HTL STREFA S A
MICRON, droplet pen needle 79152020-02-03
HTL STREFA S A
MICRON, droplet pen needle 79142020-02-03
HTL STREFA S A
LEADER, pen needles 84722020-01-21
HTL STREFA S A
droplet ® pen needles 79102020-01-20
HTL STREFA S A
LEADER, pen needles 84712019-12-27
HTL STREFA S A
LEADER, pen needles 84702019-12-27
HTL STREFA S A
LEADER, pen needles 84692019-12-27
HTL STREFA S A
LEADER, pen needles 84682019-12-27
HTL STREFA S A
LEADER, pen needles 84672019-12-27
HTL STREFA S A
droplet ® personal lancets 71622019-12-09
HTL STREFA S A
droplet ® personal lancets 71672019-12-09
HTL STREFA S A
droplet ® personal lancet 71062019-12-09
HTL STREFA S A
droplet ® personal lancet 71052019-12-09
HTL STREFA S A
droplet ® personal lancet 72072019-12-09
HTL STREFA S A
droplet ® personal lancet 72062019-12-09
HTL STREFA S A
Medlance Plus, safety lancet 72852019-11-11
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
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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