Identity
- Trade Name
- Sugarmate, Web Application EUDAMEDFDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Sugarmate EUDAMED
- Model / Reference
- 1008181 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018992619 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850018992TF-0009372MA EUDAMED
- Direct Marketing DI
- 00850018992619 EUDAMED
- FDA Product Code
- PHV FDA UDI
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Self-care monitoring/reporting software 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
- Austria 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
Sugarmate, Web Application 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-0009372MA | 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 c69d06dd-d7d5-4042-a739-b123f8775479 61 fields · synced Jun 18, 2026
- FDA UDI 38515c7b-7340-4125-a76d-bd416027beff 32 fields · synced May 29, 2026