This page includes the latest FDA filings for Dysis Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Dysis Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3009142105 |
| FEI Number | 3009142105 |
| Name | DYSIS MEDICAL |
| Owner & Operator | DYSIS Medical |
| Contact Address | Gyleview House 3 Redheughs Rigg Edinburgh GB-SCT Scotland EH12 9DQ GB |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Gyleview House 3 Redheughs Rigg Edinburgh Scotland, EH12 9DQ GB |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3010628103 |
| FEI Number | 3010628103 |
| Name | DySIS Medical Inc. |
| Owner & Operator | DYSIS Medical |
| Contact Address | Gyleview House 3 Redheughs Rigg Edinburgh GB-SCT Scotland EH12 9DQ GB |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 11175 Cicero Drive Building 200 Suite 550 Alpharetta, GA 30022 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
DySIS Medical Inc. [DYSIS Medical] | TRP001 - Disposable Treatment Pipe | 2017-04-27 |
DySIS Medical Inc. [DYSIS Medical] | DSP003 - Large Disposable Speculum | 2017-04-27 |
DySIS Medical Inc. [DYSIS Medical] | DSP002 - Medium Disposable Speculum | 2017-04-27 |
DySIS Medical Inc. [DYSIS Medical] | DSP001 - Small Disposable Speculum | 2017-04-27 |
DYSIS MEDICAL | TRP001 - Disposable Treatment Pipe | 2017-04-27 |
DYSIS MEDICAL | DSP003 - Large Disposable Speculum | 2017-04-27 |
DYSIS MEDICAL | DSP002 - Medium Disposable Speculum | 2017-04-27 |
DYSIS MEDICAL | DSP001 - Small Disposable Speculum | 2017-04-27 |
DYSIS MEDICAL | DySIS Digital Colposcope | 2011-03-28 |