FDA Registration
Active
🇺🇸 United States
BIO-N2132, Hypodermic needles, 21G x 32mm
Reg #: 3010830834
·
FEI: 3004525092
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BiometerPlus USA, Inc.
- Registration Number
- 3010830834
- FEI Number
- 3004525092
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 48531 Warm Springs Blvd., #416
- City
- Fremont
- State
- CA
- ZIP
- 94539
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191644
Owner / Operator
- Firm Name
- BiometerPlus USA, Inc.
- Operator Number
- 10046647
- Address
- 48531 Warm Springs Blvd., #416
- City
- Fremont
- State
- CA
- Postal Code
- 94539
- Country
- US
- Correspondent
- Jian Zhou
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-11-14 |
Proprietary Names
BIO-N2132, Hypodermic needles, 21G x 32mm
BIO-N1832, Hypodermic needles, 18G x 32mm
BIO-N2516, Hypodermic needles, 25G x 16mm
BIO-N2032, Hypodermic needles, 20G x 32mm
BIO-N2232, Hypodermic needles, 22G x 32mm
BIO-N2138, Hypodermic needles, 21G x 38mm
BIO-N2038, Hypodermic needles, 20G x 38mm
BIO-N2713, Hypodermic needles, 27G x 13mm
BIO-N2238, Hypodermic needles, 22G x 38mm
BIO-N2325, Hypodermic needles, 23G x 25mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility