This page includes the latest FDA filings for Smilelab Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Smilelab Co L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3013735968 |
| FEI Number | 3013735968 |
| Name | Kyou Hee Lee |
| Owner & Operator | Smilelab Co., Ltd. |
| Contact Address | 464 Dunchon-daero, Suite 1004, Jungwon-g Seongnam-si KR-41 Gyeonggido 13229 KR |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 627 6th St Lake Oswego, OR 97034 US |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
|---|---|---|
Kyou Hee Lee [Smilelab Co., Ltd.] | Smilereader ovulation test kit (pregnancy test) | 2019-04-09 |
Kyou Hee Lee [Smilelab Co., Ltd.] | PREGABLE ovulation test kit (pregnancy test) | 2019-04-09 |
Kyou Hee Lee [Smilelab Co., Ltd.] | Smilereader ovulation test kit (pregnancy test) | 2019-04-09 |
Kyou Hee Lee [Smilelab Co., Ltd.] | PREGABLE ovulation test kit (pregnancy test) | 2019-04-09 |
Kyou Hee Lee [Smilelab Co., Ltd.] | Smilereader ovulation test kit (pregnancy test) | 2017-07-20 |
Kyou Hee Lee [Smilelab Co., Ltd.] | Smilereader ovulation test kit (ovulation test) | 2017-07-20 |
Kyou Hee Lee [Smilelab Co., Ltd.] | PREGABLE ovulation test kit (ovulation test) | 2017-07-20 |