FDA Registration
Active
🇪🇪 Estonia
Ionisos Baltics OU
Reg #: 3003617485
·
FEI: 3003617485
·
Expires 2026
Products
10
Proprietary Names
12
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Ionisos Baltics OU
- Registration Number
- 3003617485
- FEI Number
- 3003617485
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kurvi tee 406a, Alliku
- City
- Saue vald Harjumaa
- Country
- EE
Owner / Operator
- Firm Name
- EPIONE BIDCO
- Operator Number
- 10042490
- Address
- 415 allee de Frenes, bat Squale
- City
- LIMONEST
- State
- Rhone
- Postal Code
- 69760
- Country
- FR
- Correspondent
- Alexandra Basset
US Agent
- Business Name
- Dawa Medical LLC
- Contact Name
- Stephan Toupin
- Address
- 7320 Nw 12th St Ste 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2024-06-05 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2025-01-23 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2024-04-16 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2025-02-06 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-12-04 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2023-03-16 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2020-01-17 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2021-01-05 |
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2023-01-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-11 |
Proprietary Names
iCare TP022 Probes
iCare TP01s Probes
LiDCOunity v2 Hemodynamic Monitoring System
LIDCOunity v2
Femoral Epidrill
Patellar Epidrill
3C Patch Needle Holder
3C Patch Device
OTS Hip
OTS Hip Solution Emphasys
Tracer set
OTS Hip Solution Pinnacle
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)