Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009403363

FEI Number

3009403363

Entity Name

AEGIS LIFESCIENCES PRIVATE LIMITED

City/State/Country

Ahmedabad Gujarat, IN

Establishment Address

215/216, Mahagujarat Industrial Estate, Ahmedabad Gujarat 382213, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aegis Lifesciences Private Limited (Owner Number: 10087601)

Owner / Operator Contact Address

215/216, Mahagujarat Industrial Estate, Ahmedabad, IN-GJ 382213, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDI-PVA Surgi-PVA Surgi-ORC® MEDI-PVA Surgi-PVA SURGISPON® Surgi-PVA MEDI-PVA NASPON POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) -ORCA Foam SPLINT, INTRANASAL SEPTAL - ORCA Foam Surgi-PVA MEDI-PVA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2025-12-26
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2026-01-21
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2025-09-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-02-03
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2023-12-11
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2023-12-11
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2025-09-25

Official Correspondent

Mohit Gupta

US Agent Details

Madan Chilakuri Business: Pharma Regulatory Consultants LLC Email: mc@pharmaregllc.com Phone: (207) 7564065

Related Public Records

Same Entity

Aegis Lifesciences Private Limited

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
K080022	Vascular Solutions, Inc.	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	2008-12-09
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

Similar Registrations

Registration Number	Establishment Name	Location
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
1319660	ISOMEDIX OPERATIONS INC.	CHESTER, NY, US
1211998	Beaver-Visitec International, Inc.	Waltham, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009403363. Last updated year: 2026. Please use registration number 3009403363 when referencing this establishment in official correspondence.