Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009613036

FEI Number

3009613036

Entity Name

MERIL LIFE SCIENCES PVT. LTD.

City/State/Country

Vapi Gujarat, IN

Establishment Address

Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi Gujarat 396191, IN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Meril Life Sciences Pvt. Ltd. (Owner Number: 10046054)

Owner / Operator Contact Address

Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi, IN-GJ 396191, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MESIRE Balloon Sinus Dilatation System Aspiron(TM) Aspiration Catheter Mozec - Rx PTCA Balloon Dilatation Catheter Mozec NC-Rx PTCA Balloon Dilatation Catheter MESIRE Light Guide Cable MESIRE - Balloon Sinus Dilatation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2018-03-17
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2019-05-01
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2014-01-29
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-08-22
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2018-10-13
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-10-13

Official Correspondent

Neelam Dangra

US Agent Details

Kaiyumkhan Patel Business: Meril Inc. Email: kaiyum.patel@merillife.com Phone: (267) 5158405

Related Public Records

Same Entity

Meril Life Sciences Pvt. Ltd.

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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K232458	ABBOTT MEDICAL	JETiHydrodynamic Thrombectomy System	2023-12-19
K243549	ABBOTT MEDICAL	JETi Hydrodynamic Thrombectomy System	2025-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

Similar Registrations

Registration Number	Establishment Name	Location
3027828125	MAJiK MEDICAL SOLUTIONS PRIVATE LIMITED	Hyderabad Telangana, IN
3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
9615857	INSTRUMENTARIUM SURGICAL CORP., INC.	TERREBONNE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009613036. Last updated year: 2026. Please use registration number 3009613036 when referencing this establishment in official correspondence.