BIOPOLYMER SYSTEMS

FDA Device Registration & Listing · Tiruvallur Tamil Nadu, IN · Registration 3038620645

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038620645
FEI Number
3038620645
Entity Name
BIOPOLYMER SYSTEMS
City/State/Country
Tiruvallur Tamil Nadu, IN
Establishment Address
P6, SIDCO Industrial Estate, Thirumazhisai, Chennai, Tiruvallur Tamil Nadu 600124, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIOPOLYMER SYSTEMS (Owner Number: 10093479)
Owner / Operator Contact Address
P6, SIDCO Industrial Estate, Thirumazhisai, Chennai, Tiruvallur, IN-TN 600124, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Endosys CareKIT Sterilization Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-05-22

Official Correspondent

K V Santharam

US Agent Details

Nidesh Khatri Business: Eurotech Assessment & Certification Services, LLC Email: info@eurotechworld.net Phone: (914) 3594932

Related Public Records

Same Entity

BIOPOLYMER SYSTEMS
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-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038620645. Last updated year: 2026. Please use registration number 3038620645 when referencing this establishment in official correspondence.
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