FDA Registration
Active
🇵🇱 Poland
Pure X
Reg #: 3012119662
·
FEI: 3012119662
·
Expires 2025
Products
1
Proprietary Names
32
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIVANTOS SP. Z O.O.
- Registration Number
- 3012119662
- FEI Number
- 3012119662
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Baltycka 6
- City
- Poznan
- Country
- PL
Owner / Operator
- Firm Name
- WSAUD A/S
- Operator Number
- 10060087
- Address
- Nymoellevej 6
- City
- Lynge
- State
- Hovedstaden
- Postal Code
- DK-3540
- Country
- DK
- Correspondent
- La-Shaunda Joseph
US Agent
- Business Name
- WS Audiology USA, Inc.
- Contact Name
- La-Shaunda Joseph
- Address
- 185 Commerce Drive
- City
- Hauppauge
- State
- NY
- ZIP
- 11788
- Country
- US
- [email protected]
- Phone
- 561 7859321
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2019-03-28 |
Proprietary Names
Pure X
Motion
Motion Nx
CROS X
Pure Charge&Go
Signia Active X
Insio Charge&Go
Styletto X
Motion X
Pure Charge&Go X
Insio IX
Intuis 4
CROS AS
Signia Active
Pure AX
Silk Charge&Go IX
Motion Charge&Go X
Insio Nx
Signia Pure
Active Pro IX
Signia Active IX
Motion Charge&Go SP X
Insio Charge&GO AX
CROS
Signia Active Pro
Styletto IX
Motion Charge&Go P X
Pure Charge&Go IX
EARCARE-R
Silk X
Pure Charge&Go T AX
Intuis 3
Establishment Types
Manufacture Medical Device