Identity
- Trade Name
- Eversense® Adhesive Patches, 10-pack Clear FDA UDI
- Generic Name
- Implantable glucose monitoring system FDA UDI
- Device Name
- Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. FDA UDI
- Model / Reference
- FG-6400-01-300 FDA UDI
- Description
- Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00817491021335 FDA UDI
- PMA Number
- P160048 FDA UDI
- FDA Product Code
- QCD FDA UDIQHJ FDA UDI
- GMDN Term
- Implantable glucose monitoring system FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable glucose monitoring system
Eversense® Adhesive Patches, 10-pack Clear by Senseonics, Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable glucose monitoring system.
- Eversense Adhesive Patches, 10-pack White — SENSEONICS, INCORPORATED · Class III
- Eversense NOW Mobile App Android — SENSEONICS, INCORPORATED · Class II
- Eversense 365 Mobile Application (iOS) — 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
Cleared under the same submission
P160048 also covers:
- Eversense Adhesive Patches, 10-pack White — SENSEONICS, INCORPORATED
- Eversense Charging Cable — SENSEONICS, INCORPORATED
- Eversense E3 Adhesive Patches Kit, 180-pack — SENSEONICS, INCORPORATED
- Eversense E3 Insertion Tools Kit — SENSEONICS, INCORPORATED
- Eversense E3 Pouch Containing Sensor and Holder — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - DME — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - Retail — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit – Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Retail — SENSEONICS, INCORPORATED
- Eversense Insertion Tools Kit — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 826e5f07-19d8-4e1b-93f9-637f6ace6b3b 37 fields · synced May 30, 2026