FDA Registration
Active
🇨🇭 Switzerland
OEM component, Overmolded Needle Array, for use in IB-Stim non-implanted nerve stimulator
Reg #: 3001110146
·
FEI: 3001110146
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Theia Holding SA
- Registration Number
- 3001110146
- FEI Number
- 3001110146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Jardiniere 153
- City
- La Chaux-de-Fonds Neuchatel
- Country
- CH
Regulatory Submissions
- 510(k) Number
- DEN180057
Owner / Operator
- Firm Name
- HL Technology SA
- Operator Number
- 10038408
- Address
- Jardiniere 153
- City
- La Chaux-de-Fonds
- State
- Neuchatel
- Postal Code
- 2300
- Country
- CH
- Correspondent
- Adrian banderet
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | QHH | Class 2 | Gastroenterology, Urology | No | 2021-06-14 |
Proprietary Names
OEM component, Overmolded Needle Array, for use in IB-Stim non-implanted nerve stimulator
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)