Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010011359

FEI Number

3010011359

Entity Name

BIORAD MEDISYS PVT. LTD.

City/State/Country

Pune Maharashtra, IN

Establishment Address

Survey No. 48/3 & 48/7, Pashan Sus Road,, Sus Village, Taluka Mulshi, Pune Maharashtra 411021, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIORAD MEDISYS PVT. LTD. (Owner Number: 10052015)

Owner / Operator Contact Address

Survey No. 48/3 & 48/7, Pashan Sus Road,, Sus Village, Taluka Mulshi, Pune, IN-MH 411021, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INDOVASIVE, INDOSCOPE, ELITE, INDOSCOPE-CN Arthroscope Kit CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY URS Forcep Biopsy Forcep RETRIVO/BI RETRIVO; Indovasive/B-indovasvive/ Biorad Medisys/Biorad Medisyz/Automed GRASPEK, INDOVASIVE INDOVASIVE BIONBDC, INDOVASIVE Biliary Drainage Catheter/ Biliary Plastic Stent BIOBILBAO, INDOVASIVE Bilbao Dotter Catheter Nasal Biliary Drainage Catheter Dilator, catheter PEG Kit INDOVASIVE Ureteral Catheter UROX; BI-UROX, Indovasive/B-indovasvive/Biorad Medisys/Biorad Medisyz/Automed CHASE;BI-CHASE/Indovasive/ B-indovasvive/ Biorad Medisys/Biorad Medisyz/Automed Braided Shaft catheter CHAISE/Indovasive/B-indovasvive/Biorad Medisys/Biorad Medisyz/Automed/BI Double lumen catheter Chiba Needle Indovasive/BI/ B indovasvive/Biorad Medisys/Biorad Medisyz/Automed Perk basket X Circle rigid tip Perk basket balloon shape Rigid tip Helical Basket (with tip and without tip) Perk basket balloon shape Flexible tip StoneStop Retrieval Coil GPaw stone basket Stone Grasper Zero tip basket (balloon shape) Perk basket GPaw Flexible tip Segura basket (with tip without tip) Perk basket GPaw rigid tip Perk basket X Circle Flexible tip X Circle stone basket Cholangioscope Kit Cysto nephroscope kit INDOVASIVE, INDOSCOPE, ELITE, INDOSCOPE-CN Ureteroscope Kit Esophageal Dilator INDOVASIVE PTFE Guidewire CHASE/ INDOVASIVE Hydrophilic Guidewire Stripped hydrophilic tip Guidewire Stripped Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-04-02
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2016-06-01
FFF	Cover, Biopsy Forceps	Gastroenterology, Urology	Class 1	876.1075	2024-04-02
PTT	Biliary Catheter For Irrigation And Contrast Injection, Exempt	Gastroenterology, Urology	Class 2	876.5010	2024-04-02
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2016-06-01
PRM	Enteral Administration Kit (Adult & Pediatric)	Gastroenterology, Urology	Class 2	876.5980	2024-04-02
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-04-02
QFZ	Gastroenterology-Urology Accessories To A Biopsy Instrument	Gastroenterology, Urology	Class 1	876.1080	2024-04-02
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2016-06-01
FGS	Carrier, Sponge, Endoscopic	Gastroenterology, Urology	Class 2	876.1500	2024-04-02
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2024-04-02
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

BIORAD MEDISYS 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
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

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9611278	Stengelin Medical GmbH	TUTTLINGEN Baden-Wurttemberg, DE
3012358417	Arthrocare Corporation	Coyol Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010011359. Last updated year: 2026. Please use registration number 3010011359 when referencing this establishment in official correspondence.