Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011452218

FEI Number

3011452218

Entity Name

ENDOSYS HEALTHCARE INDIA PVT. LTD

City/State/Country

Mumbai Maharashtra, IN

Establishment Address

92-C, Govt. Industrial Estate,, Opp. Sahyadri Nagar, Kandivali West,, Mumbai Maharashtra 400067, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ENDOSYS HEALTHCARE INDIA PVT. LTD (Owner Number: 10048917)

Owner / Operator Contact Address

92-C, Govt. Industrial Estate,, Opp. Sahyadri Nagar, Kandivali West,, Mumbai, IN-MH 400067, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENDOSYS Suture Grasper / Passer Mediflex ENDOSYS Mediflex Surgical Stays Port Free Retractor - Versa Lifter Band Mediflex Port Free Retractor - T-PEA Lifter Mediflex Port Free Retractor - Versa Lifter Band Port Free Retractor - T-PEA Lifter ENDOSYS Suture Grasper / Passer Mediflex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2015-03-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-03-19
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-03-19

Official Correspondent

Devang Mehta

US Agent Details

Dhiren Mehta Business: Allwin Medical Devices, Inc. Email: dhiren@allwinmedical.com Phone: (714) 4880408

Related Public Records

Same Entity

ENDOSYS HEALTHCARE INDIA 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
2031768	Nobles Medical Technologies II, Inc.	Fountain Valley, CA, US
3009956343	SUTURE EASE, INC.	Galt, CA, US
8020712	LOCKDOWN MEDICAL LIMITED	Redditch Worcestershire, GB
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
2953359	Sterigenics U.S. LLC	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011452218. Last updated year: 2026. Please use registration number 3011452218 when referencing this establishment in official correspondence.