Tandem Diabetes Care, Inc.

Certificate MDR 761832

Rev. R001Supplemented

Valid until: Aug 31, 2030

Certificate MDR 761832 is a valid Technical documentation issued to Tandem Diabetes Care, Inc. and registered in EUDAMED. Valid until August 31, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 761832
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 761832R001

Validity

Issued: Jun 1, 2026
Valid from: Jun 1, 2026
Valid until: Aug 31, 2030

Notified body

Notified body: BSI Group The Netherlands B.V.
Notified body SRN: 2797
Notified body country: Netherlands

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

MDR 761832SupplementedDec 17, 2025 → Aug 31, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified1

1 scope

t:slim X2 Insulin Pump
0389152TF00098599U

Documents

LanguagesEN