Identity
- Trade Name
- Tandem Source EUDAMEDFDA UDI
- Generic Name
- Ambulatory insulin infusion pump software, data-display FDA UDI
- Device Name
- Tandem Source EUDAMEDTandem Source Web Application v 3.X FDA UDI
- Model / Reference
- 1011061 EUDAMEDFDA UDI
- Description
- Tandem Source Web Application v 3.X FDA UDI
Identifiers
- Catalog Number
- 1011061 FDA UDI
- Primary DI / UDI-DI
- 00389152106113 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850018992TF-0009817MT EUDAMED
- Direct Marketing DI
- 00389152106113 EUDAMED
- FDA Product Code
- PHV FDA UDI
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Ambulatory insulin infusion pump software, data-display FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2120 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Tandem Source by Tandem Diabetes Care, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850018992TF-0009817MT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
- EUDAMED SRN
- US-MF-000031791
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED adf0aaa4-3207-4315-bd5e-ee53a15d1f79 61 fields · synced Jun 17, 2026
- FDA UDI a9ffc0e9-45d1-4c92-a751-f6c65331eb4d 34 fields · synced May 30, 2026