FDA Registration
Active
🇮🇳 India
ClearSpec Single Use Vaginal Speculum
Reg #: 3010437413
·
FEI: 3010437413
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHAILY ENGINEERING PLASTICS LIMITED
- Registration Number
- 3010437413
- FEI Number
- 3010437413
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Survey No. 363 & 366, Rania, Taluka - Savli,
- City
- Vadodara Gujarat
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K130046
Owner / Operator
- Firm Name
- Shaily Engineering Plastics Limited
- Operator Number
- 10046413
- Address
- Survey No. 363 & 366, Rania, Taluka - Savli,
- City
- Vadodara
- State
- Gujarat
- Postal Code
- 391780
- Country
- IN
- Correspondent
- Amit Sanghvi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2014-03-19 |
Proprietary Names
ClearSpec Single Use Vaginal Speculum
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)