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t:slim X2 3mL Cartridge with Sterile Syringe and Needle

EUDAMED

Class IIa (EU MDR)

Ref 1013858

by Tandem Diabetes Care, Inc.

Identity

Trade Name
t:slim X2 3mL Cartridge with Sterile Syringe and Needle EUDAMED
Device Name
t:slim X2 3mL Cartridge with Sterile Syringe and Needle EUDAMED
Model / Reference
1013858 EUDAMED

Identifiers

Primary DI / UDI-DI
00389152000978 EUDAMED
Basic UDI-DI
00389152TF0009858PBC EUDAMED
EMDN Code
Z1204021685 PORTABLE MICROINFUSION INSTRUMENTS - CONSUMABLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Medical Purpose
The t:slim X2™ 3 mL cartridge is indicated for use with the t:slim X2 insulin pump for the continuous subcutaneous delivery of insulin. Refer to the t:slim X2 insulin pump user guide for complete Indications for Use. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

t:slim X2 3mL Cartridge with Sterile Syringe and Needle by Tandem Diabetes Care, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.
EUDAMED SRN
US-PR-000041891

Sources (1)

  • EUDAMED 2c931377-ce6b-454c-bfc2-044042363f54 61 fields · synced Oct 6, 2026