Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027645738

FEI Number

3027645738

Entity Name

ANGIPLAST PVT. LTD.

City/State/Country

Kheda Gujarat, IN

Establishment Address

Survey No. 589/1, 590 at Village Vasna Bujarg, Dholka Road, Kheda Gujarat 387411, IN

Establishment Type(s)

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

Owner / Operator

Angiplast Pvt. Ltd. (Owner Number: 10029529)

Owner / Operator Contact Address

Survey No. 589/1, 590, Village Vasna Buzarg, Dholka Road, Kheda, IN-GJ 387411, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

URO URINARY SUSPENSORY SYSTEM ILLUMINATED YANKAUER SUCKER B-HEX Pupil Expander

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-12-23
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2013-04-09
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2009-05-27
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2018-04-19
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2022-02-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2013-04-09

Official Correspondent

Asitt Shah

US Agent Details

Earl G. Christensen Business: Sterigear, Inc. Email: echristensen@sterigear.com Phone: (801) 6073211

Related Public Records

Same Entity

Angiplast Pvt. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3016577639	ACOSTA MEDICAL GROUP INC.	Houston, TX, US
3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3013187142	ENDURE INDUSTRIES, INC.	Homer, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027645738. Last updated year: 2026. Please use registration number 3027645738 when referencing this establishment in official correspondence.