AUROLAB

FDA Device Registration & Listing · MADURAI Tamil Nadu, IN · Registration 9710098

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710098
FEI Number
3002957101
Entity Name
AUROLAB
City/State/Country
MADURAI Tamil Nadu, IN
Establishment Address
No. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI Tamil Nadu 625020, IN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
AUROLAB (Owner Number: 9039871)
Owner / Operator Contact Address
1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI, IN-TN 625020, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LGY Trypan Blue Hematology Class 1 864.1850 2024-01-10
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2022-09-01
LYX Media, Corneal Storage Unknown Class U N/A 2022-12-12
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2007-10-18
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2013-02-15
LWL Fluid, Intraocular Ophthalmic Class 3 886.4275 2015-10-15
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2013-07-31
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2015-10-15
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2015-02-11
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2007-10-18
PPM General Purpose Reagent Pathology Class 1 864.4010 2011-06-18
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2025-08-09
LZP Aid, Surgical, Viscoelastic Ophthalmic Class 3 886.4275 2015-09-24
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2015-07-23
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2018-04-27
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2014-09-20
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2023-05-27
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2012-05-15
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2020-08-06

Official Correspondent

R. KRISHNA KUMAR

US Agent Details

Krishnakumar Venkateswaran Business: Imai LLC Email: krishna.venkat70@gmail.com Phone: (281) 7331495

Related Public Records

Same Entity

AUROLAB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2009 Surgical Specialties Corp 2
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0530-2015 Abbott Medical Optics Inc (AMO) 3
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Z-2062-2017 Abbott Medical Optics Inc. (AMO) 3
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2063-2017 Abbott Medical Optics Inc. (AMO) 3
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Z-2064-2017 Abbott Medical Optics Inc. (AMO) 3
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710098. Last updated year: 2026. Please use registration number 9710098 when referencing this establishment in official correspondence.
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