FDA Registration
Active
🇮🇹 Italy
SBM SISTEMI SRL
Reg #: 3013488369
·
FEI: 3013488369
·
Expires 2026
Products
5
Proprietary Names
23
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SBM SISTEMI SRL
- Registration Number
- 3013488369
- FEI Number
- 3013488369
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- via Coazze 4
- City
- Rivalta di Torino
- Country
- IT
Owner / Operator
- Firm Name
- SBM SISTEMI SRL
- Operator Number
- 10054993
- Address
- via Coazze 4
- City
- Rivalta di Torino
- State
- IT-TO
- Postal Code
- 10040
- Country
- IT
- Correspondent
- Matteo Barberis
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Katie Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2022-07-27 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2017-05-23 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2017-05-23 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2022-04-29 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2025-11-25 |
Proprietary Names
OS1000
ES600X
TDEX
ES600
APOLLO 1
OS1000X
TDE
ICP OSA
TEARSCOPE
SLIT LAMP
ICP MGD
SLIT LAMP PLUS
IDRA
HDA-100
TFA
DSLC 200
DEM 100
DRY EYE SCAN
ICP IOL
ICP
ACTIVA MED
IDRA X
TFA-2
Establishment Types
Manufacture Medical Device