FDA device listing
AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop),C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18…
FDA device listing 2060209016 · NIKKISO CO., LTD.
Key facts
| Proprietary names | AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop),C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series |
|---|---|
| Owner/operator | NIKKISO CO., LTD. |
| Owner/operator number | 8031561 |
| Premarket submissions | K242176 |
| Product codes | KOC |
| Device names | KOC - Accessories, Blood Circuit, Hemodialysis |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5820 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | M.E.Nikkiso Vietnam Co., Ltd., NIKKISO CO., LTD., NIKKISO CO., LTD. - SHIZUOKA PLANT |
| Establishment registrations | 8031561, 3014638255, 3027859369 |
| FEI numbers | 3002807721, 3014638255, 3027859369 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database