This page includes the latest FDA filings for Cyclomedica Australia Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Cyclomedica Australia Pty L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 8043631 | ||||||||
| FEI Number | 3009638066 | ||||||||
| Name | Karen Wolfe-Kerker | ||||||||
| Owner & Operator | CYCLOMEDICA AUSTRALIA PTY LTD | ||||||||
| Contact Address | Unit 4 1 The Crescent Kingsgrove AU-NSW New South Wales 2208 AU | ||||||||
| 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 | 1422 Elbridge Payne Rd Suite 200 Chesterfield, MO 63017 US | ||||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Cyclomedica Australia Pty Limited | Prescription Medication | 2024-02-12 |
| Cyclomedica Australia Pty Limited | Prescription Medication | 2024-02-09 |
| CYCLOMEDICA AUSTRALIA PTY LTD | Technegas Plus System 25000 | 2023-11-14 |
| CYCLOMEDICA AUSTRALIA PTY LTD | Patient Administration Set 17836 | 2023-11-08 |
| Cyclomedica Australia Pty Limited | Prescription Medication | 2023-10-25 |
| CYCLOMEDICA AUSTRALIA PTY LTD | Patient Administration Set 17830 | 2023-04-19 |
Karen Wolfe-Kerker [CYCLOMEDICA AUSTRALIA PTY LTD] | Technegas Patient Administration Se | 2007-10-24 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020090125908 | Sydney,Australia -> Oakland, California | PATIENT ADMIN SET PATIENT ADMIN SET X 50, STD SPARE PARTS FOR A TECHNEGAS GENERATOR - WHICH IS A MEDICAL RESPIRATORY MACHINE | 311 PCS |
| 2019092815858 | Sydney,Australia -> Oakland, California | MEDICAL RESPIRATORY DEVICE | 311 PCS |
| 2019051328409 | Sydney,Australia -> Oakland, California | MEDICAL EQUIPMENT TOTAL PKGS 311 PIECES FREIGHT PREPAID (T)+905-565-0116 X 222 | 311 PCS |