FDA Registration
Active
🇮🇹 Italy
NCS LAB SRL
Reg #: 3011410128
·
FEI: 3011410128
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- NCS LAB SRL
- Registration Number
- 3011410128
- FEI Number
- 3011410128
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Pola Esterna 4/12
- City
- Carpi Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K160500
Owner / Operator
- Firm Name
- NCS Lab Srl
- Operator Number
- 10050099
- Address
- Via Pola Esterna 4/12
- City
- Carpi
- State
- Modena
- Postal Code
- 41012
- Country
- IT
- Correspondent
- Matteo Mantovani
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2016-11-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-10-12 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2019-09-27 |
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2021-08-30 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-08-30 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2022-11-21 |
Proprietary Names
Elite SPK
Compasso
Elite SPK Kit
Taylor Stitcher Instrument with STN Needle
GT Tunneler
Showmotion
Shoulder Pacemaker TM
Establishment Types
Manufacture Medical Device