Data / Medical devices / India / SMB Corporation Of India
SMB Corporation Of India: FDA-registered device maker in Valsad Gujarat, India, 1 510(k) clearance
SMB Corporation Of India is registered with the FDA (registration 3012551896) in Valsad Gujarat, India. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012551896
- Address
- Plot No. 156 GIDC, Umbergaon, Valsad Gujarat, India, 396170
- Owner or operator
- SMB Corporation of India (10083802)
- Roles
- Manufacturer
- First device listed
- December 21, 2021
- Registered through
- 2026
- Brand names listed
- FORCEP, Pozzi Tenaculum Forceps, REMOVER, INTRAUTERINE DEVICE, SMB Amniotomy Hook, SMB Cervical Dilator, SMB Hypodermic syringe with or without Needle, SMB Luer lock disposable syringe, Sound, Uterine and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amniotome | HGE | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Manufacturer | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2024 | K231558 | SMB Luer lock disposable syringe | FMF | Substantially Equivalent | Smb Corporation of India | accessdata.fda.gov |
Compare with other makers
- All makers of Remover, Intrauterine Device, Contraceptive, Hook-Type
- All makers of Forceps
- All makers of Scissors, Medical, Disposable
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Sound, Uterine
Updated January 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.