Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611088

FEI Number

3002807599

Entity Name

MEDIONICS INTERNATIONAL, INC.

City/State/Country

MARKHAM Ontario, CA

Establishment Address

114 ANDERSON AVE., MARKHAM Ontario L6E 1A5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIONICS INTERNATIONAL, INC. (Owner Number: 8020321)

Owner / Operator Contact Address

114 ANDERSON AVE., MARKHAM, CA-ON L6E 1A5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993149

PMA Number

N/A

All Registered Proprietary Names

Stylet #SST-650 Peritoneal Dialysis Catheter Adapter #PCA-1010 Peritoneal Dialysis Catheter #SNCA-5262L Peritoneal Dialysis Catheter #CA-2262 Peritoneal Dialysis Catheter #CP-1241 Peritoneal Dialysis Catheter #SI-1231 Peritoneal Dialysis Catheter #SNPS-53113 Peritoneal Dialysis Catheter Adapter #TA-300 Peritoneal Dialysis Catheter Adapter #TA-200 Peritoneal Dialysis Catheter #SNCP-5243L Peritoneal Dialysis Catheter #PSNA-100 Peritoneal Dialysis Catheter #CA-1162 Peritoneal Dialysis Catheter #SNCA-5263LFD Peritoneal Dialysis Catheter #CA-1157 Peritoneal Dialysis Catheter #SA-1247 Peritoneal Dialysis Catheter #SA-1248K Peritoneal Dialysis Catheter #SA-1255 Peritoneal Dialysis Catheter #CA-2272

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2013-06-04
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2007-12-05

Official Correspondent

MAHESH AGARWAL

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

MEDIONICS INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611088. Last updated year: 2026. Please use registration number 9611088 when referencing this establishment in official correspondence.