FDA Registration
Active
🇮🇳 India
AUROLAB
Reg #: 9710098
·
FEI: 3002957101
·
Expires 2026
Products
20
Proprietary Names
28
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- AUROLAB
- Registration Number
- 9710098
- FEI Number
- 3002957101
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN
- City
- MADURAI Tamil Nadu
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K221759
Owner / Operator
- Firm Name
- AUROLAB
- Operator Number
- 9039871
- Address
- 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN
- City
- MADURAI
- State
- Tamil Nadu
- Postal Code
- 625020
- Country
- IN
- Correspondent
- R. KRISHNA - KUMAR
US Agent
- Business Name
- Imai LLC
- Contact Name
- Krishnakumar Venkateswaran
- Address
- 37 Cottage lane
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
- [email protected]
- Phone
- 281 7331495
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Trypan Blue | LGY | Class 1 | Hematology | No | 2024-01-10 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2022-09-01 |
| Media, Corneal Storage | LYX | Class U | Unknown | No | 2022-12-12 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2007-10-18 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-02-15 |
| Fluid, Intraocular | LWL | Class 3 | Ophthalmic | No | 2015-10-15 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2013-07-31 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2015-10-15 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2015-02-11 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2007-10-18 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2011-06-18 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2025-08-09 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2015-09-24 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2018-04-27 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2014-09-20 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2023-05-27 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2012-05-15 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2020-08-06 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2015-09-24 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2025-08-09 |
Proprietary Names
Auroblue
Aurosling
Cornisol
AUROLAB NYLON SUTURES
Sutralene Polypropylene Sutures
Aurosil
AuroChart
CATVision
Glide
Iris Retractor
AUROLAB SILK SUTURES
Povidone Iodine 5% Solution
Aurodone
Falcon i
Aurovisc
SUTRALON
QuickSee
ESee
Polycryl
i - Nova
Auroslim
Nanocut
Aurosleek
AuroTrocar
Sutrazorb
Intraocular Lens
SUTRASILK
Aurolab Omniglo
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device