Identity
- Trade Name
- Simplera™ FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Simplera App / Guardian Connect Guardian Application (iOS) EUDAMEDSFTWR MMT-8400 1.1 CGM MODULE IOS US FDA UDI
- Model / Reference
- MMT-8400 EUDAMEDFDA UDI
- Description
- SFTWR MMT-8400 1.1 CGM MODULE IOS US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000587796 EUDAMED00763000721350 FDA UDI
- Basic UDI-DI
- 0763000B000122279 EUDAMED
- PMA Number
- P160007 FDA UDI
- FDA Product Code
- PQF FDA UDI
- EMDN Code
- Z120402160103 PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS EUDAMED
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Simplera™ by Medtronic Minimed, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
- Dexcom G7 GSS (151) — Dexcom · Class II
- Dexcom G7 AR Overlay 10-Pack — Dexcom · Class I
- Stelo Glucose Biosensor (1pk) — Dexcom · Class II
- Dexcom G7 GSS (155) — Dexcom · Class II
- Dexcom Discovery Sensor 1 Pack — Dexcom · Class II
- Bigfoot Unity Diabetes Management System — BIGFOOT BIOMEDICAL, INC. · Class II
- Dexcom G7 Receiver — Dexcom · Class II
- Bigfoot Unity Diabetes Management System — BIGFOOT BIOMEDICAL, INC. · Class II
Cleared under the same submission
P160007 also covers:
- Charger — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Minimed, Inc.
Sources (2)
- FDA UDI aa603a02-7fda-4b89-9df2-c0bfed89ea54 35 fields · synced Jun 20, 2026
- EUDAMED 29bc999b-d96a-4637-86b7-0c6f3214dde1 61 fields · synced Jun 20, 2026