FDA Registration
Active
🇺🇸 United States
SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.
Reg #: 3000143502
·
FEI: 3000143502
·
Expires 2026
Products
13
Proprietary Names
13
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.
- Registration Number
- 3000143502
- FEI Number
- 3000143502
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 330 SMC Drive
- City
- Somerset
- State
- WI
- ZIP
- 54025
- 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
- Correspondent
- SHU - LI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2022-07-18 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-07-18 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2018-06-12 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2012-11-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-08 |
| Penile Implant Surgical Accessories | QGA | Class 1 | Gastroenterology, Urology | No | 2020-04-06 |
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2007-02-16 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2020-12-09 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2012-11-26 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2012-11-26 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2013-01-16 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2012-11-26 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2019-05-16 |
Proprietary Names
CEREPAK Detacher
FitLife EE Total Face Mask
ATTUNE
LIFEPORT KIDNEY PE
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
S 4Point Headgear with Clips RP Kit
Capstrap with Clips RP Kit
Performax Headgear 9 Pack
Performax Headgear 5 Pack
Bronchoscopy Elbow Kit
FitLife SE Total Face Mask
Amara View FFM
Amara
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)