Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027031650

FEI Number

3027031650

Entity Name

Novartis Pharmaceutical Manufacturing GmbH

City/State/Country

Langkampfen Tirol, AT

Establishment Address

Biochemiestrasse 10, Langkampfen Tirol 6336, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Novartis Pharmaceuticals Corporation (Owner Number: 10028011)

Owner / Operator Contact Address

One Health Plaza, East Hanover, NJ 07936, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Glatopaject

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	2024-01-04

Official Correspondent

Karen Costa

US Agent Details

Karen Costa Business: NOVARTIS PHARMACEUTICALS CORPORATION Email: karen.costa@novartis.com Phone: (862) 3083443

Related Public Records

Same Entity

Novartis Pharmaceuticals Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002037047	Novartis Manufacturing NV	Puurs-Sint-Amands Antwerpen, BE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027031650. Last updated year: 2026. Please use registration number 3027031650 when referencing this establishment in official correspondence.