FDA device listing
BW-400B,BW-400L,BW-400V,BW-403B,BW-411B,BW-412T,MAJ-1339,MAJ-1888
FDA device listing 1063718910 · OLYMPUS CORPORATION
Key facts
| Proprietary names | BW-400B,BW-400L,BW-400V,BW-403B,BW-411B,BW-412T,MAJ-1339,MAJ-1888 |
|---|---|
| Owner/operator | OLYMPUS CORPORATION |
| Owner/operator number | 9067818 |
| Product codes | MNL |
| Device names | MNL - Accessories, Cleaning Brushes, For Endoscope |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | AIZU OLYMPUS CO., LTD., Aomori Olympus Co., Ltd. Hirosaki Site, AOMORI OLYMPUS CO., LTD. Kuroishi Site, Gyrus ACMI, Inc., KEYMED (Medical & Industrial Equipment) Ltd, OLYMPUS MEDICAL SYSTEMS CORP., Olympus Vietnam Co. Ltd., OLYMPUS WINTER & IBE GMBH, SHIRAKAWA OLYMPUS CO., LTD. |
| Establishment registrations | 8010047, 9610595, 9610773, 9611174, 9614641, 3002808148, 3008040402, 3011050570, 3014769442 |
| FEI numbers | 1000162602, 3002807795, 3002807798, 3002808148, 3002964398, 3003995201, 3008040402, 3011050570, 3014769442 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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