FDA Registration
Active
🇨🇭 Switzerland
DISTALMOTION SA
Reg #: 3033118964
·
FEI: 3033118964
·
Expires 2026
Products
2
Proprietary Names
14
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- DISTALMOTION SA
- Registration Number
- 3033118964
- FEI Number
- 3033118964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Route de la Corniche 3B
- City
- Epalinges Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K233312
Owner / Operator
- Firm Name
- Distalmotion SA
- Operator Number
- 10091399
- Address
- Route de la Corniche 3B
- City
- Epalinges
- State
- Vaud
- Postal Code
- 1066
- Country
- CH
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S. Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Software Controlled Endoscope And Instrument Holder | QZB | Class 2 | Gastroenterology, Urology | No | 2024-11-05 |
| Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | SDD | Class 2 | General, Plastic Surgery | No | 2025-11-28 |
Proprietary Names
DEXTER ENDOSCOPE ARM
Dexter L6 Accessory Tray
Dexter L6 Sterile Interface
Dexter L6 Monopolar Scissors
Dexter L6 Needle Holder
Dexter L6 Monopolar Hook
Dexter L6 Incision Pointer
Dexter L6 Robot
Dexter L6 Bipolar Maryland Dissector
Dexter L6 Emergency Release Tool
Dexter L6 System
Dexter L6 Bipolar Johann Grasper
Dexter L6 Handle Grip
Dexter L6 Endoscope Cart
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility