Medinotec Inc

FDA Device Registration & Listing · Dix Hills, NY, US · Registration 3029663075

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
3029663075
FEI Number
3029663075
Entity Name
Medinotec Inc
City/State/Country
Dix Hills, NY, US
Establishment Address
200 Broadhollow Road, Dix Hills, NY 11747, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Medinotec Inc (Owner Number: 10088772)
Owner / Operator Contact Address
200 Broadhollow Rd, Melville, NY 11747, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K241562
PMA Number
N/A

All Registered Proprietary Names

OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2025-03-14

Official Correspondent

Lyndon Oldfield

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medinotec Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029663075. Last updated year: 2026. Please use registration number 3029663075 when referencing this establishment in official correspondence.
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