This page includes the latest FDA filings for Htl Strefa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Htl Strefa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3006142663 |
| FEI Number | 3006142663 |
| Name | HTL-STREFA, INC. |
| Owner & Operator | HTL-STREFA S.A. |
| Contact Address | ADAMOWEK 7 -- OZORKOW PL-NOTA 95-035 PL |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3005 Chastain Meadows Pkwy Ste 300 MARIETTA, GA 30066 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Htl-Strefa, Inc. | Otc Medication | 2023-11-18 |
| Htl-Strefa, Inc. | Otc Medication | 2022-11-05 |
| Htl-Strefa, Inc. | Otc Medication | 2022-02-05 |
| Htl-Strefa, Inc. | Alcohol Prep Pads | 2022-02-04 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | droplet pen needle | 2018-03-28 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | DropSafe Safety Pen Needle | 2017-12-20 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | droplet pen needle | 2015-07-08 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | ergoLance | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | droplet personal lancets | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | droplet lancing device | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | Safe-T-Lance Plus | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | PROLANCE | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | MediSafe SOLO | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | MEDLANCE | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | MEDLANCE plus | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | HaemoFine | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | HAEMOLANCE | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | HAEMOLANCE Plus | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | Acti-Lance | 1996-10-31 |
HTL-STREFA, INC. [HTL-STREFA S.A.] | Acti-Lance baby | 1996-10-31 |
| NCAGE Code | 7TKQ9 | HTL-STREFA, INC.!DBA HTL STREFA SA |
| CAGE Code | 7TKQ9 | HTL-STREFA, INC. HTL STREFA SA |
| S.A.M. Registration | 7TKQ9 [799137406] | HTL-STREFA, INC. HTL STREFA SA |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020092289531 | Gdynia,Poland -> Savannah, Georgia | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-133 INVOICE VAT NO.: (S)FSE-488 20 EX HS-CODE : 90 18 39 | 42 PKG |
| 2020092289531 | Gdynia,Poland -> Savannah, Georgia | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-133; 2020-154 INVOICE VAT NO.: (S)FSE-485 20 EX HS-CODE : 90 18 39 | 42 PKG |
| 2020091772896 | Gdynia,Poland -> Philadelphia, Pennsylvania | 21 PACKAGES MEDICAL EQUIPMENT KGM MTQ LANCETS FOR DIABETICS P.O.: 2020-165 INVOICE VAT NO.: (S)FSE-465 20 EX | 21 PKG |
| 2020091664802 | Gdynia,Poland -> New York/Newark Area, Newark, New Jersey | MEDICAL PRODUCT LANCETS FOR DIABETICS P.O.: 2020-161 4512881443 INVOICE VAT NO.: (S)FSE-491 20 EX HS-CODE : 90 18 39 | 20 PKG |
| 2020091664938 | Gdynia,Poland -> New York/Newark Area, Newark, New Jersey | LANCETS FOR DIABETICS MEDICAL EQUIPMENT P.O.: 2020-172; 2020-175 INVOICE VAT NO.: (S)FSE-489 20 EX HS: 90183900 | 10 PKG |
| 2020091664961 | Gdynia,Poland -> New York/Newark Area, Newark, New Jersey | LANCETS FOR DIABETICS MEDICAL EQUIPMENT P.O.: 2020-164 INVOICE VAT NO.: (S)FSE-490 20 EX HS-CODE : 90 18 39 | 10 PKG |
| 2020091245907 | Gdynia,Poland -> Philadelphia, Pennsylvania | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-165; 2020-166 INVOICE VAT NO.: (S)FSE-453 20 EX HS-CODE : 90 18 39 | 42 PKG |
| 2020091245907 | Gdynia,Poland -> Philadelphia, Pennsylvania | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-146; 2020-147; 2020-165 INVOICE VAT NO.: (S)FSE-452 20 EX HS-CODE : 90 18 39 | 42 PKG |
| 2020090992568 | Gdynia,Poland -> Savannah, Georgia | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-060; 2020-133 INVOICE VAT NO.: (S)FSE-454 20 EX HS-CODE : 90 18 39 | 40 PKG |
| 2020090992568 | Gdynia,Poland -> Savannah, Georgia | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-133 INVOICE VAT NO.: (S)FSE-451 20 EX HS-CODE : 90 18 39 | 40 PKG |
| 2020090812381 | Gdynia,Poland -> Philadelphia, Pennsylvania | MEDICAL EQUIPMENT LANCETS FOR DIABETICS P.O.: 2020-146 INVOICE VAT NO.: (S)FSE-437 20 EX | 21 PKG |