Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007092328

FEI Number

3007092328

Entity Name

SURU INTERNATIONAL PVT LTD

City/State/Country

DAHANU Maharashtra, IN

Establishment Address

PLOT # 5 & 6, POONAMIA COMP., SARAVALI, JAWHAR RD., DAHANU Maharashtra 401602, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SURU INTERNATIONAL PVT LTD (Owner Number: 10091867)

Owner / Operator Contact Address

C-6, SONA UDYOG WING 3, ANDHERI (E), MUMBAI, Mumbai, IN-MH 400069, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SURU SURU SURUVENT DUO SURUVENT SOLO SURUVENT SURU SURU SURU-LEG BAG SURU-BABY BAG SURU-UBAG SURU-URIMETER SURUSTAP SURU SURUDRAIN SURU SURU SURU SURU SURU

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2024-11-09
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2024-11-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2024-11-09
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2024-11-09
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2025-07-24
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-11-09
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2024-11-09
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-07-24
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-11-09
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2024-11-09
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2024-11-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2024-11-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2024-11-09
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-11-09

Official Correspondent

JITESH SHAH

US Agent Details

Charmi Shah Email: charmi.shah@gmail.com Phone: (425) 7707126

Related Public Records

Same Entity

SURU INTERNATIONAL 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-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007092328. Last updated year: 2026. Please use registration number 3007092328 when referencing this establishment in official correspondence.