FDA Registration
Active
🇸🇪 Sweden
AprioMed AB
Reg #: 3007664053
·
FEI: 3007664053
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- AprioMed AB
- Registration Number
- 3007664053
- FEI Number
- 3007664053
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Virdings alle 28
- City
- UPPSALA
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K193268
Owner / Operator
- Firm Name
- AprioMed AB
- Operator Number
- 9071836
- Address
- Virdings alle 28
- City
- Uppsala
- State
- SE-C
- Postal Code
- 754 50
- Country
- SE
- Correspondent
- Katrin Svensson
US Agent
- Business Name
- IZI Medical Products
- Contact Name
- Qiang Cao
- Address
- 5 Easter Ct Ste J
- City
- Owings Mills
- State
- MD
- ZIP
- 21117
- Country
- US
- [email protected]
- Phone
- 443 8262997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2020-03-05 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2005-06-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-03-29 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-12-27 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2014-04-16 |
Proprietary Names
AprioCore plus
SEESTAR
BONOPTY COAXIAL BONE BIOPSY
Morrison Steerable Needle
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Bonopty Adapter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device