Sandoz GmbH

Address:Biochemiestrasse 10,Langkampfen Tirol,AT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Introducer, Syringe Needle (KZH) (1)

Premarket Exempt

Clear

Glatopaject® - 57613421039603 Catalog Number : 49020084

Device Description : The Glatopaject® is a reusable injection device for the subcutaneous injection o The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatiramer Acetate Injection) Pre-Filled Syringe.

Device Class :

Duns Number: 300220969

Premarket Exempt : No

Product Code : KZH

Prescription Use : No

Device Count : 1

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