FDA Registration
Active
🇯🇵 Japan
KOBAYASHI PHARMACEUTICAL CO., LTD.
Reg #: 3002324535
·
FEI: 3002324535
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- KOBAYASHI PHARMACEUTICAL CO., LTD.
- Registration Number
- 3002324535
- FEI Number
- 3002324535
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KDX Kobayashi Doshomachi Bldg, 4-10, Doshomachi 4-chome
- City
- Chuo-ku Osaka
- Country
- JP
Owner / Operator
- Firm Name
- KOBAYASHI AMERICA MANUFACTURING, LLC
- Operator Number
- 10049550
- Address
- 245 KRAFT DRIVE
- City
- Dalton
- State
- GA
- Postal Code
- 30721
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2016-10-13 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2019-09-04 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2015-06-17 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2017-11-03 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2016-10-13 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2018-04-26 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device