This page includes the latest FDA filings for Infinitt Healthcare Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| KOREA REP OF | KOREA EXCHANGE (KOSDAQ) | 071200 | DUNS 688319156 |
| Registration Number | 3003989064 | ||||||
| FEI Number | 3003989064 | ||||||
| Name | David Smarro | ||||||
| Owner & Operator | INFINITT Healthcare Co., Ltd. | ||||||
| Contact Address | 12F Daerung Post Tower III, 182-4 Guro-Dong, Guro-Gu SEOUL KR-NOTA 08378 KR | ||||||
| Official Correspondent |
| ||||||
| US Agent |
| ||||||
| Importing Logistics Registration |
| ||||||
| Importing Logistics Registration |
| ||||||
| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 755 Memorial Parkway Suite 304 Phillipsburg, NJ 08865 US | ||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| INFINITT Healthcare Co.,Ltd. | INFINITT PACS | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | INFINITT ULite | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Xelis Dental | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Xelis Cardiac | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Xelis Fusion | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Xelis 3D | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Xelis | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | INFINITT Cardiology PACS | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | STARPACS | 2023-10-18 |
| INFINITT Healthcare Co.,Ltd. | Reformat Gateway | 2023-06-19 |
| INFINITT Healthcare Co.,Ltd. | STARPACS Dental | 2023-06-19 |
| INFINITT Healthcare Co.,Ltd. | RapidiaColon System | 2023-06-19 |
| INFINITT Healthcare Co.,Ltd. | STARPACS Orthopedics System | 2023-06-19 |
| INFINITT Healthcare Co.,Ltd. | INFINITT PACS, INFINITT G3, INFINITT Mammo | 2023-06-09 |
| INFINITT Healthcare Co.,Ltd. | INFINITT RT Mobile | 2022-09-02 |
| INFINITT Healthcare Co.,Ltd. | Xelis Dental 2.0 | 2021-11-26 |
| INFINITT Healthcare Co.,Ltd. | INFINITT RT PACS | 2021-11-26 |
Infinitt Healthcare Co.,Ltd. | Xelis Dental 2.0 | 2020-04-14 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT RT PACS | 2020-03-17 |
Infinitt Healthcare Co.,Ltd. | Infinitt RT PACS | 2020-02-13 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT PACS 7.0 | 2017-12-03 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT MAMMO 7.0 | 2017-12-03 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT G7 PACS | 2017-12-03 |
Infinitt Healthcare Co.,Ltd. | Infinitt PACS 7.0 | 2017-10-27 |
David Smarro [INFINITT Healthcare Co., Ltd.] | ULite | 2017-04-14 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT ULite | 2017-04-14 |
David Smarro [INFINITT Healthcare Co., Ltd.] | Xelis Cardiac | 2013-01-07 |
David Smarro [INFINITT Healthcare Co., Ltd.] | Xelis Fusion | 2013-01-07 |
David Smarro [INFINITT Healthcare Co., Ltd.] | Xelis 3D | 2013-01-07 |
David Smarro [INFINITT Healthcare Co., Ltd.] | XELIS DENTAL | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | XELIS | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | XELIS Colon | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT Cardiology | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT Cardiology PACS | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT PACS | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT Mammo | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | INFINITT G3 | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | Reformat Gateway | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | STARPACS Dental | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | RapidiaColon System | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | STARPACS Orthopedics System | 2011-02-20 |
David Smarro [INFINITT Healthcare Co., Ltd.] | STARPACS | 2011-02-20 |