FDA Registration
Active
🇮🇳 India
Stylet for Bulb Trans Ultra and Bulb Trans Star
Reg #: 9617744
·
FEI: 3006279007
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Allwin Medical Devices Pvt. Ltd.
- Registration Number
- 9617744
- FEI Number
- 3006279007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot No. 223, 230, and 221, Surat Special Economic Zone, Sachin
- City
- Surat Gujarat
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K200248
Owner / Operator
- Firm Name
- Allwin Medical Devices
- Operator Number
- 9036357
- Address
- 53-CD, KANDIVALI INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W)
- City
- MUMBAI, MAHARASTRA
- State
- IN-NOTA
- Postal Code
- 400 104
- Country
- IN
- Correspondent
- Rakhee Oza
US Agent
- Business Name
- Allwin Medical Devices Inc.
- Contact Name
- Dhiren Mehta
- Address
- 3305 E, Miraloma Ave, Suite 176
- City
- Anaheim
- State
- CA
- ZIP
- 92806
- Country
- US
- [email protected]
- Phone
- 714 5721709
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2020-08-13 |
Proprietary Names
Stylet for Bulb Trans Ultra and Bulb Trans Star
Stylet for Pro Embryo Trans, Pro Echo Trans, and Twinkle Embryo Trans
Pro Echo Trans Embryo Transfer Catheter
Twinkle Pro Embryo Transfer Catheter
Bulb Trans Star Embryo Transfer Catheter
Bulb Trans Ultra Embryo Transfer Catheter
Pro Embryo Trans Embryo Transfer Catheter
Trial Transfer Catheter for Embryo Trans
Twinkle Embryo Trans Embryo Transfer Catheter
Soft Obturator for Pro Echo Trans
Echo Trans Embryo Transfer Catheter
Embryo Trans Embryo Transfer Catheter
Soft Obturator for Twinkle Pro Embryo Trans
Soft Obturator for Pro Embryo Trans
Stylet for Embryo Trans, Echo Trans, Twinkle Embryo Trans
Twinkle Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator
Twinkle Pro Embryo Trans Embryo Transfer Catheter with Stylet
Pro Embryo Trans Embryo Transfer Catheter with Stylet
Trial Transfer Catheter for Echo Trans
Establishment Types
Manufacture Medical Device