FDA Registration
Active
🇺🇸 United States
AMBI, INC.
Reg #: 3008061617
·
FEI: 3008061617
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- AMBI, INC.
- Registration Number
- 3008061617
- FEI Number
- 3008061617
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 908 Sir Francis Ave.
- City
- Capitola
- State
- CA
- ZIP
- 95010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K942810
Owner / Operator
- Firm Name
- Ambi Inc.
- Operator Number
- 10030464
- Address
- 908 Sir Francis Ave.
- City
- Capitola
- State
- CA
- Postal Code
- 95010
- Country
- US
- Correspondent
- Jill E Valcarcel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| LDQ | No | 2009-10-06 | |||
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2014-04-03 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2014-04-03 |
| Insulin Vial Protector/Holder | OJL | Class 1 | Physical Medicine | No | 2014-04-03 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2009-10-06 |
Proprietary Names
Cold Pouch
Insul-eze
auto-Lancet
Ambi-Lancet
Insul-Caps
Inject-Ease
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device