FDA Registration
Active
🇮🇳 India
AUSA Medical Device Pvt Ltd
Reg #: 3015924373
·
FEI: 3015924373
·
Expires 2026
Products
20
Proprietary Names
34
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- AUSA Medical Device Pvt Ltd
- Registration Number
- 3015924373
- FEI Number
- 3015924373
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot no. 15B Bommasandara Industrial Area, Anekal Taluk
- City
- Bangalore Karnataka
- Country
- IN
Owner / Operator
- Firm Name
- Adroit USA Inc
- Operator Number
- 10037845
- Address
- 1043 Serpentine Lane, Suite A
- City
- Pleasanton
- State
- CA
- Postal Code
- 94566
- Country
- US
- Correspondent
- Arpan Bajaj
US Agent
- Business Name
- Adroit USA Inc
- Contact Name
- Arpan Bajaj
- Address
- 1043 Serpentine Lane, Suite A
- City
- Pleasanton
- State
- CA
- ZIP
- 94566
- Country
- US
- [email protected]
- Phone
- 510 2991796
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2026-03-02 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2025-05-08 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2023-11-08 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2026-03-02 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2025-09-24 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2025-09-24 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2011-08-24 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2019-06-20 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2019-06-20 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2019-06-20 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2024-06-13 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2026-03-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2026-03-10 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2026-03-02 |
| Central Venous Catheter With Manual Insertion System | SEF | Class 2 | General Hospital | No | 2026-04-10 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2023-05-08 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2023-03-31 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2019-06-20 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2026-06-15 |
| Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | PWJ | Class 2 | Obstetrics/Gynecology | No | 2026-03-02 |
Proprietary Names
Diablo Strain Relief
OneMark
NEEDLE, TROCAR W/ECHOBLAST - 21G
51679622-02
Percutaneous Access Needle with Echogenic Tip
51679622-01
NEEDLE, TROCAR W/ECHOBLAST - 18G
Jedi 8FR Strain Relief
FNA
Expect EUS Aspiration Needle
FNB
Encor Probe
DBS Counterweight
Vercise System
Tension Guide Sub Assembly
16TW SIgmoid Cannula Subassy
Fixate
Merlot Strain Relief
Clottriever Components
Slotted Needle, 17G
Expect EUS Slimline Needle
Accustick
Vertiflex Instrument Platform (VIP) Kit
Acquire EUS FNB Needle
HH88EX
SCS Handle Sub Assembly
Entrada 2 Sub Assembly
SCS Tunneller Components
Agilis HisPro Slitter
CPS Universal II Slitter
CPS 3D Plus Slitter
Sidekick 2 Sub Assemblies
EnCor Probe
Mesh Needle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)