FDA Registration
Active
🇬🇧 United Kingdom
Bathmate Pleasure Lube
Reg #: 3032430086
·
FEI: 3032430086
·
Expires 2025
Products
1
Proprietary Names
1
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
Regulatory Submissions
- 510(k) Number
- K160211
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 |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2024-10-30 |
Proprietary Names
Bathmate Pleasure Lube
Establishment Types
Export Device to the United States But Perform No Other Operation on Device