Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616674

FEI Number

3002806521

Entity Name

MYLAN TEORANTA

City/State/Country

Co. Galway, IE

Establishment Address

Inverin, Co. Galway H91H336, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Mylan Teoranta (Owner Number: 10081157)

Owner / Operator Contact Address

Inverin, Co. Galway, IE-G H91H336, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Whisperject Tobi PodManager

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2022-06-29
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2021-03-22

Official Correspondent

No official correspondent registered.

US Agent Details

Jennifer Jeran Business: Mylan Pharmaceuticals Inc. Email: eric.pfitzenmaier@viatris.com Phone: (304) 5546818

Related Public Records

Same Entity

Mylan Teoranta

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 9616674. Last updated year: 2026. Please use registration number 9616674 when referencing this establishment in official correspondence.