FDA Registration
Active
🇮🇳 India
SUS-R - Red
Reg #: 9617744
·
FEI: 3006279007
·
Expires 2025
Products
1
Proprietary Names
11
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
- K203626
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 |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2022-02-03 |
Proprietary Names
SUS-R - Red
SUS-W - White
SUL- P - Pink
SUS-I - Ivory
SUS-Y - Yellow
SUS-B - Blue
SUS-R-WT - Red Weighted
SUL-G - Green
SUL-Y - Yellow
SUL-V - Violet
SUL-B - Blue
Establishment Types
Manufacture Medical Device