FDA Registration
Active
🇮🇳 India
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
Reg #: 3014938863
·
FEI: 3014938863
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
- Registration Number
- 3014938863
- FEI Number
- 3014938863
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit No.12, Electronic Co-operative Estate, Pune - Satara Road
- City
- Pune Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K200937
Owner / Operator
- Firm Name
- Indius Medical Technologies Pvt. Ltd.
- Operator Number
- 10058793
- Address
- Unit 12, Floors 1 and 2, Electronic Co-operative Estate, Pune - Satara Road
- City
- Pune
- State
- Maharashtra
- Postal Code
- 411009
- Country
- IN
US Agent
- Business Name
- Premkumar Reddy Medical, USA LLC
- Contact Name
- Premkumar Babu
- Address
- 808 Independence Dr
- City
- Harleysville
- State
- PA
- ZIP
- 19438
- Country
- US
- [email protected]
- Phone
- 208 8616488
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-12-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-12-13 |
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198