Identity
- Trade Name
- Sugarmate, Android Mobile Application EUDAMED
- Device Name
- Sugarmate EUDAMED
- Model / Reference
- 1008179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850018992596 EUDAMED
- Basic UDI-DI
- 0850018992TF-0009372MA EUDAMED
- Direct Marketing DI
- 00850018992596 EUDAMED
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Sugarmate, Android Mobile Application 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 | 0850018992TF-0009372MA | 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 9810500f-88cc-45b3-a828-ed474bb305e6 61 fields · synced Jun 19, 2026