Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021230784

FEI Number

3021230784

Entity Name

DISA MEDINOTEC (PTY) LTD

City/State/Country

Northriding, Johannesburg Gauteng, ZA

Establishment Address

Stand 171, Northlands Business Park, Bush Telegraph Street,, Northriding, Johannesburg Gauteng 2169, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DISA Medinotec (Pty) Ltd (Owner Number: 10083849)

Owner / Operator Contact Address

Stand 171, Northlands Business Park, Bush Telegraph Street,, Northriding, Johannesburg, ZA-GT 2169, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211894

PMA Number

N/A

All Registered Proprietary Names

Trachealator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2021-12-23

Official Correspondent

Lyndon Oldfield

US Agent Details

MARGARET VERNON Business: Biologics Consulting Email: contracts@biologicsconsulting.com Phone: (720) 8833633

Related Public Records

Same Entity

DISA Medinotec (Pty) Ltd

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 3021230784. Last updated year: 2026. Please use registration number 3021230784 when referencing this establishment in official correspondence.