Tandem Diabetes Care, Inc.

Certificate MDR 824766

Rev. R001Supplemented

Valid until: May 14, 2030

Certificate MDR 824766 is a valid Technical documentation issued to Tandem Diabetes Care, Inc. and registered in EUDAMED. Valid until May 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 824766
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 824766R001

Validity

Issued: Jun 3, 2026
Valid from: Jun 3, 2026
Valid until: May 14, 2030

Manufacturer

Manufacturer
Manufacturer SRN: US-MF-000031791
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

Linked SSCPs

SSCP REC-0022195

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

History

Status changes

Supplemented

Supersedes

MDR 824766SupplementedApr 2, 2026 → May 14, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified2

2 scopes

Tandem Mobi System
00389152TF0018738ZJ
Tandem Mobile Application
0850018992TF-0011603KR

Documents

LanguagesEN