Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017406698

FEI Number

3017406698

Entity Name

Harsoria Healthcare Pvt. Ltd. (Unit-2)

City/State/Country

Baddi Himachal Pradesh, IN

Establishment Address

KK 83/85, Kh No. 342/266, SARAJ MAJRA GUJJRAN, BADDI-JHARMAJRI ROAD, Baddi Himachal Pradesh 173205, 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. (UNIT-2) (Owner Number: 10086435)

Owner / Operator Contact Address

KK 83/85, Kh No. 342/266, SARAJ MAJRA GUJJRAN, BADDI-JHARMAJRI ROAD, BADDI, IN-HP 173205, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tourniquet Oxygen Mask U. Conn. Aerosol Mask under chin Aerosol Mask Elongated Tracheostomy Mask No tubing Trah Mask Kit All Diluters, U Conn Venturi Mask Kit All Diluters Aerosol Mask Under Lip No Tubing Oxygen Mask Oxygen Mask Elongated Manual Suction Pump Suction Catheter Manual Section Pump refill Cannister Biopsy Punch Paulsen Airway MedSource Endotracheal tubes cuffed with stylet MedSource Endotracheal tubes cuffed MedSource Endotracheal tube uncuffed with stylet MedSource Endotracheal tube uncuffed Infiltration Sets High Concentrate NRB Mask Mask, Oxygen Non-Rebreather Non-Rebreather with vent Mask Oxygen, Nonrebreather Tee Aerosol Mask Oxygen nonrebreather Non-Rebreather, w/ Univ. Conn Safety Blood Collection set Extrication Device Extremity Kit Straps Head Immobilizer Traction Leg Splint MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource 72", 60 Drop, Y-Site, Needle PRN MedSource Needleless PRN, 8", Pinch Clamp, Rotary Male Luer Lock MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN MedSource Flow Regulator, 19", Split Septum Y-Site, Side Clamp MedSource 96", 10 Drop, two (2) Split Septum Y-Sites, Flow Regulator MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource Needleless PRN, 10", Pinch Clamp, Rotary Male Luer Lock MedSource 72", 10 Drop, Y-Site, Needle PRN MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource 72", 15 Drop, Y-Site, Needle PRN MedSource 88", 60 Drop, Split Septum Y-Site, Needleless PRN MedSource Needleless PRN 6", Pinch Clamp, Rotary Male Luer Lock MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN MedSource Male Luer Lock, 21" MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN MedSource Needleless PRN, 6", Split Septum Y-Site, Side Clamp Decompression Needle INFILTRATION SETS (Single-Spike and Double-Spike) Silicone Nasopharyngeal Robertazzi Naso Airway Oxygen Regulator Brass Ohmeda Adapter Oxygen Regulator Aluminum Christmas Tree Adaptor Flow Meter Chemetron Adapter RightSpot pH Indicator Nasal Cannula Oxygen Delivery Kit Nasal Cannula curved prong Oxygen nasal Cannula Soft Cannula tubing Soft Cannula Univ. Conn. Connecting Tubing Nasal Cannula Flared Nasal Cannula Tubing Nasal Cannula Nonflared Nasal Cannula univ. Conn. Soft Cannula Cannula Nonflared Adaptor Universal Cannula Flared Yankaeur Tip only, Vented Yankaeur Tube only Yankaeur Tube only, Vented Yankaeur Tip only, Non-Vented Yankaeur Tip & Tube, Vented Yankaeur Tip & Tube, Non-Vented Pocket CPR Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-09
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-11-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-11-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-12-13
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2022-11-09
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2022-11-09
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2023-12-18
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-11-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-12-23
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2025-05-06
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2022-11-09
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-11-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-01-14
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-11-09
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2022-11-09
JLL	Tubeless Analysis, Gastric Acidity	Clinical Chemistry	Class 1	862.1320	2022-11-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-11-09
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-11-09
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2022-11-09
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-10-13
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2022-11-09

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. (UNIT-2)

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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017406698. Last updated year: 2026. Please use registration number 3017406698 when referencing this establishment in official correspondence.