FDA Registration
Active
🇮🇳 India
Auxein's DHS/DCS Plate System
Reg #: 3010303097
·
FEI: 3010303097
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Auxein medical Private limited
- Registration Number
- 3010303097
- FEI Number
- 3010303097
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area,, HSIIDC Sonipat- 131028, Haryana, INDIA
- City
- Sonipat Haryana
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K221787
Owner / Operator
- Firm Name
- Auxein Medical Pvt Ltd
- Operator Number
- 10046810
- Address
- Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial area, HSIIDC Sonepat- 131028, Haryana, INDIA, HSIIDC Sonipat- 131028, Haryana, INDIA
- City
- Sonipat
- State
- Haryana
- Postal Code
- 131028
- Country
- IN
US Agent
- Business Name
- 510K FDA Inc.
- Contact Name
- Lee Strong
- Address
- 156 E Granada Blvd
- City
- Ormond Beach
- State
- FL
- ZIP
- 32176
- Country
- US
- [email protected]
- Phone
- 386 8466037
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-05-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2024-05-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-05-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2024-05-10 |
Proprietary Names
Auxein's DHS/DCS Plate System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device