Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012551896

FEI Number

3012551896

Entity Name

SMB CORPORATION OF INDIA

City/State/Country

Valsad Gujarat, IN

Establishment Address

Plot No. 156 GIDC, Umbergaon,, Valsad Gujarat 396170, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMB Corporation of India (Owner Number: 10083802)

Owner / Operator Contact Address

Plot No. 156 GIDC, Umbergaon,, Valsad, IN-GJ 396170, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sound, Uterine SMB Hypodermic syringe with or without Needle SMB Luer lock disposable syringe REMOVER, INTRAUTERINE DEVICE scissors SMB Amniotomy Hook FORCEP SMB Cervical Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2021-12-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-03-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-03-04
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2021-12-21
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2021-12-21
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2023-07-13
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-12-21
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2024-06-01

Official Correspondent

ANUPAM RAI

US Agent Details

Robert Patane Business: J & P Management Company LLC Email: bob@hpsrx.com Phone: (540) 3756415

Related Public Records

Same Entity

SMB Corporation of India

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
3015279199	PREGNA INTERNATIONAL LIMITED	Daman Daman and Diu, IN
9680002	MARYAM TRADING	SIALKOT Punjab, PK
3008367216	Titus Medical LLC	Rock Hill, SC, US
9680254	JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.	LIANYUNGANG, JIANGSU, CN
8040179	BASHIR JAMIL & BROTHERS (PVT.), LTD.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012551896. Last updated year: 2026. Please use registration number 3012551896 when referencing this establishment in official correspondence.