Tandem Mobi System
by Tandem Diabetes Care, Inc. 4 variants
Ref 1016911
Tandem Mobi System (1016911) is a Class III device made by Tandem Diabetes Care, Inc., registered in EUDAMED on 19 May 2026 (Basic UDI-DI 00389152TF0018738ZJ) with CE/MDR certificate MDR 824766 valid until 14 May 2030, active as of 24 Oct 2026.
Active
CE MDR
Valid until
14 May 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 824766 | Date2 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 00389152TF0018738ZJ
Certificates
- MDR 824766 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 2 Sep 2026
- Expires
- 14 May 2030
- Reason
- Change approved
Timeline
- Registered EUDAMED 00389152TF0018738ZJ
- Certificate issued EUDAMED MDR 824766
- Certificate expires EUDAMED MDR 824766
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 1016911
- Primary DI / UDI-DI
- 03891526911140
- Basic UDI-DI
- 00389152TF0018738ZJ
- EMDN code
- Z120402160103 Portable insulin microinfusors connectable to continuous glucose monitoring systems
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000031791
- Authorised representative
- MDSS GmbH DE-AR-000005430
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