Identity
- Trade Name
- Eversense 365 Mobile Application (iOS) FDA UDI
- Generic Name
- Implantable glucose monitoring system FDA UDI
- Device Name
- Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts. FDA UDI
- Model / Reference
- FG-5503-06-300 FDA UDI
- Description
- Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts. FDA UDI
Identifiers
- Catalog Number
- FG-5503-06-300 FDA UDI
- Primary DI / UDI-DI
- 00817491024268 FDA UDI
- 510(k) Number
- K241335 FDA UDI
- FDA Product Code
- SBA FDA UDI
- GMDN Term
- Implantable glucose monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1357 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable glucose monitoring system
Eversense 365 Mobile Application (iOS) by Senseonics, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable glucose monitoring system.
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- Eversense NOW Mobile App Android — SENSEONICS, INCORPORATED · Class II
- Eversense® Charging Accessories Pack — SENSEONICS, INCORPORATED · Class III
- Eversense® Adhesive Patches, 30-Pack Clear — SENSEONICS, INCORPORATED · Class III
- Eversense Mobile App iOS — SENSEONICS, INCORPORATED · Class III
- Eversense Mobile App Android — SENSEONICS, INCORPORATED · Class III
- Eversense DMS — SENSEONICS, INCORPORATED · Class I
- Eversense E3 Adhesive Patches Kit, 180-pack — SENSEONICS, INCORPORATED · Class III
Cleared under the same submission
K241335 also covers:
- Eversense 365 Adhesive Patches Kit — SENSEONICS, INCORPORATED
- Eversense 365 Mobile Application (Android) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (DME) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (Provider Purchase) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (Retail) — SENSEONICS, INCORPORATED
- Eversense 365 Smart Transmitter Kit (DME) — SENSEONICS, INCORPORATED
- Eversense 365 Smart Transmitter Kit (Provider Purchase) — SENSEONICS, INCORPORATED
- Eversense 365 Smart Transmitter Kit (Retail) — SENSEONICS, INCORPORATED
- Pouch Containing Grafted Sensor and Holder, Eversense 365 — SENSEONICS, INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 3100c37c-f310-4309-8500-1d535ce374bb 36 fields · synced May 30, 2026