Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008410596

FEI Number

3008410596

Entity Name

Harsoria Healthcare Pvt. Ltd.

City/State/Country

Gurgoon Haryana, IN

Establishment Address

110-111 Phase IV Udyong Vihar, Gurgoon Haryana 122015, IN

Establishment Type(s)

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

Owner / Operator

HARSORIA HEALTHCARE PVT. LTD (Owner Number: 10086433)

Owner / Operator Contact Address

110-111 PHASE IV UDYONG VIHAR, GURGOON, IN-HR 122015, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Decompression Needle VeroTrue IV Catheter Standard IV Catheter MedSource ClearSafe Blood Control IV safety Catheter MedSource TrueSafe Blood control IV safety Catheter Vacutainer Holder TrueSafe Blood Control IV Safety Catheter ClearSafe Blood Control IV Safety Catheter ClearSafe Safety IV Catheter ClearSafe Blood Control IV Safety Catheter PurSafety R IV catheter ClearSafe Comfort Safety IV Catheter MedSource Safety IV Catheter ClearSafe Comfort with Wings IV Safety Catheter ClearSafe Comfort Blood Control IV Safety Catheter Safety Blood Collection set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-11-09
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-11-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-11-09
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2023-12-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-12-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-11-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

Emilie Andrews Business: MedSource International, LLC. Email: eandrews@medsourcelabs.com Phone: (952) 4720131

Related Public Records

Same Entity

HARSORIA HEALTHCARE 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Similar Registrations

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9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008410596. Last updated year: 2026. Please use registration number 3008410596 when referencing this establishment in official correspondence.