FDA Registration
Active
🇮🇳 India
Harsoria Healthcare Pvt. Ltd. (Unit-2)
Reg #: 3017406698
·
FEI: 3017406698
·
Expires 2026
Products
22
Proprietary Names
87
Establishment Types
6
Classifications
22
Registration Details
- Registration Name
- Harsoria Healthcare Pvt. Ltd. (Unit-2)
- Registration Number
- 3017406698
- FEI Number
- 3017406698
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KK 83/85, Kh No. 342/266, SARAJ MAJRA GUJJRAN, BADDI-JHARMAJRI ROAD
- City
- Baddi Himachal Pradesh
- Country
- IN
Owner / Operator
- Firm Name
- HARSORIA HEALTHCARE PVT. LTD. (UNIT-2)
- Operator Number
- 10086435
- Address
- KK 83/85, Kh No. 342/266, SARAJ MAJRA GUJJRAN, BADDI-JHARMAJRI ROAD
- City
- BADDI
- State
- Himachal Pradesh
- Postal Code
- 173205
- Country
- IN
US Agent
- Business Name
- MedSource International, LLC.
- Contact Name
- Emilie Andrews
- Address
- 8600 Shelby Court
- City
- Chanhassen
- State
- MN
- ZIP
- 55317
- Country
- US
- [email protected]
- Phone
- 952 4720131
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-11-09 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-11-09 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2022-11-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-12-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-11-09 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2022-11-09 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2023-12-18 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2022-11-09 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-12-23 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2025-05-06 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2022-11-09 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2022-11-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2024-05-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-01-14 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2022-11-09 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2022-11-09 |
| Tubeless Analysis, Gastric Acidity | JLL | Class 1 | Clinical Chemistry | No | 2022-11-17 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-11-09 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-11-09 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2022-11-09 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2022-11-09 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2023-12-23 |
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
IV Extension set
MedSource I.V. Administration Set
Vacutainer Holder
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Foreign Private Label Distributor