FDA Registration
Active
🇬🇧 United Kingdom
TENSCARE LTD.
Reg #: 3003446042
·
FEI: 3003446042
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- TENSCARE LTD.
- Registration Number
- 3003446042
- FEI Number
- 3003446042
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
- City
- EPSOM Surrey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K142506
Owner / Operator
- Firm Name
- TENSCARE LTD.
- Operator Number
- 9046089
- Address
- PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
- City
- EPSOM
- State
- Surrey
- Postal Code
- KT19 9BE
- Country
- GB
- Correspondent
- Saskia Eldridge-Hinmers
US Agent
- Business Name
- QA/RA Consulting Group, Inc.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Road
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2015-09-02 |
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device