FDA Registration
Active
🇹🇼 Taiwan
AVITA CORPORATION
Reg #: 9617543
·
FEI: 3003272793
·
Expires 2026
Products
10
Proprietary Names
8
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- AVITA CORPORATION
- Registration Number
- 9617543
- FEI Number
- 3003272793
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9F, NO. 78, SEC. 1,, Kwang-Fu Road
- City
- San-Chung District, New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K102554
Owner / Operator
- Firm Name
- AViTA CORPORATION
- Operator Number
- 9042237
- Address
- 9F, No. 78, Sec. 1,, Kwang-Fu Road
- City
- San-Chung District, New Taipei City
- State
- TW-NOTA
- Postal Code
- 24158
- Country
- TW
- Correspondent
- Rex Hsieh
US Agent
- Business Name
- ProMedic, LLC.
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- St Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2011-03-22 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2025-04-07 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2023-12-22 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2023-07-28 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2005-09-02 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2023-06-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-06-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-09-25 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2026-01-15 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2013-07-03 |
Proprietary Names
Baby 2-in-1 Nasal Aspirator with Sprayer (NS 13)
NS22
Nasal Aspirator NS13
AViTA Breast Pump BR10
AViTA NE 10
AViTA NE 60
AViTA NE 20
AViTA Nasal Aspirator NS22
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility