FDA device listing
Pack, Hot Or Cold, Disposable
FDA device listing 1656323313 · KOBAYASHI AMERICA MANUFACTURING, LLC
Key facts
| Owner/operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
|---|---|
| Owner/operator number | 10049550 |
| Product codes | IMD |
| Device names | IMD - Pack, Hot Or Cold, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5710 |
| Review panels | Physical Medicine |
| Registered establishments | HEFEI KOBAYASHI DAILY PRODUCTS CO., LTD., Hefei Kobayashi Daily Products Co., LTD., Xiyou Road 4479 Facility, KOBAYASHI AMERICA MANUFACTURING, LLC, Kobayashi Pharmaceutical (China) Co.,Ltd., KOBAYASHI PHARMACEUTICAL CO., LTD. |
| Establishment registrations | 3002324535, 3002965034, 3003079019, 3004201320, 3031604327 |
| FEI numbers | 3002324535, 3002965034, 3003079019, 3004201320, 3031604327 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Repackager/Relabeler, Specification Developer, Foreign Exporter |
| 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