FDA Registration
Active
🇨🇭 Switzerland
LEM Surgical AG
Reg #: 3040312029
·
FEI: 3040312029
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LEM Surgical AG
- Registration Number
- 3040312029
- FEI Number
- 3040312029
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Morgenstrasse 136
- City
- Bern
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K243326
Owner / Operator
- Firm Name
- LEM Surgical AG
- Operator Number
- 10093626
- Address
- Morgenstrasse 136
- City
- Bern
- State
- CH-BE
- Postal Code
- 3018
- Country
- CH
- Correspondent
- Yossi Bar
US Agent
- Business Name
- LEM Surgical, Inc.
- Contact Name
- Christopher Prentice
- Address
- 4830 W Kennedy Blvd Ste 130
- City
- Tampa
- State
- FL
- ZIP
- 33609
- Country
- US
- [email protected]
- Phone
- 727 4538318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-06-13 |
Proprietary Names
Dynamis Robotic Surgical System
Establishment Types
Manufacture Medical Device