Identity
- Trade Name
- Tandem Mobi 2 mL Cartridge EUDAMED
- Device Name
- Tandem Mobi 2 mL Cartridge EUDAMED
- Model / Reference
- 1015285 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00389152001012 EUDAMED
- Basic UDI-DI
- 0389152TF0009858CHN EUDAMED
- EMDN Code
- Z1204021685 PORTABLE MICROINFUSION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Tandem Mobi 2 mL Cartridge 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0389152TF0009858CHN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
- EUDAMED SRN
- US-MF-000031791
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d8075ad9-3ae1-4d6d-bb57-11846f98facb 61 fields · synced Jun 20, 2026