FDA Registration
Active
🇬🇧 United Kingdom
Bathmate Cushion Rings
Reg #: 3032430086
·
FEI: 3032430086
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XERSIZER LTD
- Registration Number
- 3032430086
- FEI Number
- 3032430086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 1 Caldervale Road
- City
- Horbury Wakefield
- Country
- GB
Owner / Operator
- Firm Name
- Xersizer Ltd
- Operator Number
- 10091753
- Address
- Unit 1 Caldervale Road
- City
- Horbury
- State
- Wakefield
- Postal Code
- WF4 5ER
- Country
- GB
- Correspondent
- Joe Mosalski
US Agent
- Business Name
- Heyer Regulatory Solutions
- Contact Name
- Sheila Hemeon-Heyer
- Address
- 125 Cherry Ln
- City
- Amherst
- State
- MA
- ZIP
- 01002
- Country
- US
- [email protected]
- Phone
- 413 3308578
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2024-10-30 |
Proprietary Names
Bathmate Cushion Rings
Bathmate Hydro Vibe
Bathmate Hydro
Bathmate Vibe Bullet
Bathmate Hydroxtreme
Bathmate Power Rings (Barbarian, Gladiator, Spartan, Maximus)
Bathmate Hydromax
Establishment Types
Export Device to the United States But Perform No Other Operation on Device