FDA Registration
Active
🇺🇸 United States
KOBAYASHI AMERICA MANUFACTURING, LLC
Reg #: 3003079019
·
FEI: 3003079019
·
Expires 2026
Products
7
Proprietary Names
1
Establishment Types
5
Classifications
7
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Registration Details
- Registration Name
- KOBAYASHI AMERICA MANUFACTURING, LLC
- Registration Number
- 3003079019
- FEI Number
- 3003079019
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 245 KRAFT DR
- City
- Dalton
- State
- GA
- ZIP
- 30721
- Country
- US
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, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2018-04-26 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2015-06-17 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2016-10-13 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2017-11-03 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2019-09-04 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2016-10-13 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2023-08-02 |
Proprietary Names
HotHands Therapy Warming Earplugs
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device