This page includes the latest FDA filings for Flexray Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3014134519 | ||||||||||
| FEI Number | 3014134519 | ||||||||||
| Name | FLEXRAY MEDICAL | ||||||||||
| Owner & Operator | FLEXRAY MEDICAL | ||||||||||
| Contact Address | Speditorvej 1 Aalborg DK-81 Region Nordjylland 9000 DK | ||||||||||
| 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 | Speditorvej 19 Aalborg Region Nordjylland, 9000 DK | ||||||||||
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
|---|---|---|
FLEXRAY MEDICAL | Optima MR430S 1.5T | 2019-09-02 |
FLEXRAY MEDICAL | GE Discovery VCT64 | 2019-05-14 |
FLEXRAY MEDICAL | GE Discovery VCT64 | 2019-05-14 |
FLEXRAY MEDICAL | Biograph 64 | 2019-01-07 |
FLEXRAY MEDICAL | Biograph 40 | 2019-01-07 |
FLEXRAY MEDICAL | Biograph 64 | 2019-01-07 |
FLEXRAY MEDICAL | Biograph 40 | 2019-01-07 |
FLEXRAY MEDICAL | GE Discovery | 2018-09-21 |
FLEXRAY MEDICAL | GE Discovery | 2018-09-21 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 201908159269 | Stadersand,Federal Republic of Germany -> Port Everglades, Florida | SIEMENS BIOGRAPH 64 PETCT | 13 PKG |
| 2019081417503 | Stadersand,Federal Republic of Germany -> Port Everglades, Florida | SIEMENS BIOGRAPH 64 PETCT | 13 PKG |
| 2019081221410 | Stadersand,Federal Republic of Germany -> Charleston, South Carolina | SIEMENS BIOGRAPH 64 PETCT | 13 PKG |
| 2019051517129 | Stadersand,Federal Republic of Germany -> Charleston, South Carolina | MEDICAL EQUIPMENT | 7 PKG |
| 2019050445265 | Stadersand,Federal Republic of Germany -> Charleston, South Carolina | MEDICAL EQUIPMENT | 7 PKG |
| 2019022030773 | Bremerhaven,Federal Republic of Germany -> Port Everglades, Florida | USED 2007 SIEMENS BIOGRAPH 40 PETCT | 8 PKG |
| 2018102375801 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | USED 2006 GE DISCOVERY STE8 PETCT | 11 PKG |
| 2018102249084 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | USED 2006 GE DISCOVERY STE8 PETCT | 11 PKG |