This page includes the latest FDA filings for Biobot Surgical Pte L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008548323 | ||||||||||
| FEI Number | 3008548323 | ||||||||||
| Name | Rene van de Zande | ||||||||||
| Owner & Operator | Biobot Surgical Pte. Ltd. | ||||||||||
| Contact Address | 79 Ayer Rajah Crescent #04-05 SINGAPORE SG-NOTA 139955 SG | ||||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 US | ||||||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| BIOBOT SURGICAL PTE. LTD. | iSR'obot Kit AS-00006415 | 2024-06-24 |
| BIOBOT SURGICAL PTE. LTD. | iSR'obot Kit AS-00005786 | 2024-06-24 |
| BIOBOT SURGICAL PTE. LTD. | iSR'obot Kit AS-00006416 | 2024-06-24 |
| BIOBOT SURGICAL PTE. LTD. | iSR'obot Biopsy Kit G4AA610 | 2024-06-24 |
| BIOBOT SURGICAL PTE. LTD. | 2024-03-08 | |
| BIOBOT SURGICAL PTE. LTD. | AS-00005787 AS-00005787 | 2024-03-08 |
Biobot Surgical Pte Ltd | ISR’obot Mona Lisa 2.0 | 2021-12-22 |
Biobot Surgical Pte Ltd | ISR'obot Mona Lisa 1.0 | 2021-07-08 |
Rene van de Zande [Biobot Surgical Pte. Ltd.] | iSR'obot Biopsy Kit | 2018-03-01 |
Rene van de Zande [Biobot Surgical Pte. Ltd.] | iSR'obot Biopsy Kit | 2018-03-01 |
Rene van de Zande [Biobot Surgical Pte. Ltd.] | iSR'obot MRI-US Fusion | 2018-03-01 |
Biobot Surgical Pte Ltd | ISR'obot Biopsy Kit | 2017-05-16 |
BIOBOT SURGICAL PTE LTD | ISR'obot MRI-US Fusion | 2016-10-06 |
Rene van de Zande [Biobot Surgical Pte. Ltd.] | iSR'bot Mona Lisa | 2014-05-12 |
Rene van de Zande [Biobot Surgical Pte. Ltd.] | iSR'bot Mona Lisa | 2014-05-12 |
BIOBOT SURGICAL PTE LTD | ISR'OBOT MONA LISA | 2013-06-07 |
BIOBOT SURGICAL PTE LTD | ISROBOT MONA LISA | 2011-08-12 |