Minimed Go App (OUS iOS)
Ref MMT-8601Model MMT-8600
Active
Valid until
Not listed
FDA recalls
2 ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0763000B000327286 00199150038961 | Date6 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00199150038961 | Date14 Jun 2026 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Ongoing Z-0265-2027
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.
-
- Ongoing Z-2778-2026
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- MiniMed Go
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
- Device Name
- Minimed Go App (OUS iOS)
- Model / Reference
- MMT-8600, MMT-8601
- Primary DI / UDI-DI
- 00199150038961 EUDAMED00199150038985 GUDID
- Basic UDI-DI
- 0763000B000327286
- 510(k) Number
- FDA Product Code
- NDC
- EMDN Code
- W020106019099 Various diabetes monitoring instruments - other
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.1890
- Special Device Type
- Software
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00199150038961 | 00199150038985 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000023100
- Authorised representative
- Medtronic B.V. NL-AR-000006050
Other devices from Medtronic Minimed, Inc.
Properties
Other properties (22)
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No