Identity
- Trade Name
- TempTraq® FDA UDI
- Generic Name
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
- Device Name
- TempTraq EUDAMEDTempTraq Patient Android App FDA UDI
- Model / Reference
- N/A EUDAMEDTempTraq Patient Android App FDA UDI
- Description
- TempTraq Patient Android App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851203006111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851203006111 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TempTraq by Blue Spark Technologies, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201977 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00851203006111 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Spark Technologies, Inc.
- EUDAMED SRN
- US-MF-000026609
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED ee84aedf-6983-4111-a15f-ad516ab7ac66 61 fields · synced Aug 2, 2026
- FDA UDI fc158e0d-5d5f-4c16-ab40-03b3bcc03e90 35 fields · synced May 30, 2026
- FDA 510(k) K201977 1 fields · synced May 18, 2026