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MiniMed App MMT-8098

by Medtronic Minimed, Inc.

Ref MMT-8098Model MMT-8098 / MMT-8099

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

2 Jul 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier GMED SAS

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000318488 Basic UDI-DI 00199150002375UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150002375 UDI-DI Date25 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 40571 Active

    Technical documentation EU MDR

    Certifier
    GMED SAS 0459
    Issued
    3 Jul 2026
    Expires
    2 Jul 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MiniMed App
Generic Name
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device Name
MiniMed App (iOS) / MiniMed App (Android)
Model / Reference
MMT-8098, MMT-8098 / MMT-8099
Primary DI / UDI-DI
00199150002375
Basic UDI-DI
0763000B000318488
510(k) Number
FDA Product Code
NDC
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
GMDN Term
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
868.1890
Special Device Type
Software
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K253701)

Other devices from Medtronic Minimed, Inc.

See all devices from Medtronic Minimed, Inc. →

Properties

  • Lot / Batch Number

Other properties (23)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No