FDA Registration
Active
🇦🇺 Australia
Hydropik Pro
Reg #: 3003491259
·
FEI: 3003491259
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ERSKINE DENTAL
- Registration Number
- 3003491259
- FEI Number
- 3003491259
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5-9 Kylie Street
- City
- MACKSVILLE New South Wales
- Country
- AU
Owner / Operator
- Firm Name
- Erskine Dental
- Operator Number
- 9079903
- Address
- 5-9 KYLIE STREET, --
- City
- MACKSVILLE, NSW
- State
- New South Wales
- Postal Code
- 2447
- Country
- AU
US Agent
- Business Name
- FDABasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 Sw 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-12-17 |
Proprietary Names
Hydropik Pro
Hydropik Ultra
Hydropik Mini
Hydropik
Establishment Types
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility