This page includes the latest FDA filings for Asahi Kasei Medical America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Asahi Kasei Medical America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3006396296 |
| FEI Number | 3006396296 |
| Name | ASAHI KASEI MEDICAL AMERICA INC. |
| Owner & Operator | ASAHI KASEI MEDICAL AMERICA INC. |
| Contact Address | 1855 Elmdale Avenue Glenview IL 60026 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1855 Elmdale Avenue Glenview, IL 60026 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| ASAHI KASEI MEDICAL AMERICA INC. | Plasma Exchange Tubeset 066I | 2018-07-06 |
| ASAHI KASEI MEDICAL AMERICA INC. | Plasma Exchange tubeset 064I | 2018-07-06 |
ASAHI KASEI MEDICAL AMERICA INC. | Plasma Therapy Tubeset | 2013-11-25 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2018051415820 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | HEMODIALYZER INVOICE NO. - A18010 PO NO. - PO11-00753 HS CODE-8421.29 | 1106 CTN |
| 2018012228261 | Laem Chabang,Thailand -> Los Angeles, California | 180 CARTONS MEDICAL SUPPLIES DISPOSABLE MEDI CAL TUBESETS DEVICE LISTING D010456 FOR 066 I H S CODE 9018 9090 INVOICE NUMBER INO-60 0637 | 180 CTN |