FDA Registration
Active
🇨🇭 Switzerland
Incipio Devices SA
Reg #: 3013223655
·
FEI: 3013223655
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Incipio Devices SA
- Registration Number
- 3013223655
- FEI Number
- 3013223655
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Av. des Paquiers 16
- City
- St Blaise Neuchatel
- Country
- CH
Owner / Operator
- Firm Name
- Incipio Devices SA
- Operator Number
- 10089271
- Address
- Avenue des Paquiers 16
- City
- St. Blaise
- State
- Neuchatel
- Postal Code
- 2072
- Country
- CH
- Correspondent
- Chris Taylor
US Agent
- Business Name
- Regulatory/Quality Management Information Source, Inc.
- Contact Name
- Barry Sands
- Address
- 110 Haverhill Rd Ste 524
- City
- Amesbury
- State
- MA
- ZIP
- 01913
- Country
- US
- [email protected]
- Phone
- 978 8345701
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-11-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-11-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-11-22 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-11-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-11-22 |
Proprietary Names
Cup Instrument System - Instrument Tray
Offset Reamer Handle - Instrument Tray
Angled Reamer Handle - Instrument Tray
Offset Cup Impactor
Orientable Alignment Guide
Acetabular Reamer
Offset Reamer Handle
Angled Reamer Handle
Straight Reamer Handle
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198