FDA Registration
Active
🇺🇸 United States
SMC Ltd.
Reg #: 1225580
·
FEI: 3012349753
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SMC Ltd.
- Registration Number
- 1225580
- FEI Number
- 3012349753
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18 Independence Dr
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Owner / Operator
- Firm Name
- SCIENTIFIC MOLDING CORPORATION LTD
- Operator Number
- 9057460
- Address
- 330 SMC DRIVE, --
- City
- Somerset
- State
- WI
- Postal Code
- 54025
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-10-05 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2025-12-16 |
| Epinephrine Syringe | PQX | Class 2 | General Hospital | No | 2018-11-06 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2020-10-21 |
Proprietary Names
PROSOFT-PED-S
PROSOFT-INF
PROSOFT-XL
PROSOFT-ADULT
PROSOFT-PRE
PROSOFT-INT-INF
PROSOFT-NEO
PROSOFT-PED-AS
PROSOFT-PED-S1 (SMC India)
UNICORN-INF (SMC India)
UNICORN-PED (SMC India)
UNICORN-ADULT (SMC India)
PROSOFT-PED-AS1 (SMC India)
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
INBRIJA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)