FDA Registration
Active
🇮🇳 India
Tendon Stripper (Closed End), Dia 6mm
Reg #: 3010303097
·
FEI: 3010303097
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2016-01-18 |
Proprietary Names
Tendon Stripper (Closed End), Dia 6mm
Tendon Stripper (Open End), Dia 6mm
Tendon Stripper (Open End), Dia 7mm
Tendon Stripper (Closed End), Dia 8mm
Tendon Stripper (Open End), Dia 8mm
Tendon Stripper (Closed End), Dia 7mm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device