EUDAMED last updated this device on Jul 17, 2026

MMT-8401

0763000B000122279

On the marketClass IIa

Applicable legislation: —
Organization name: Medtronic MINIMED
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 00763000587802
Reference / catalog number: MMT-8401

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

MMT-8401 is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Medtronic MINIMED. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 00763000587802
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 0763000B000122279
Reference / catalog number: MMT-8401
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The Simplera Application, in combination with the Simplera Sensor, is intended for use only by patients and caregivers using a compatible mobile device and operating system, and who have sufficient experience to adjust mobile device audio and notification settings. The System is intended to communicate with digitally connected devices for the purpose of managing diabetes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)00763000587802

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z1204011502INVASIVE BLOOD SUGAR MONITORING SYSTEMS

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

MR SAFE
Consult healthcare professional before use
Refer to instruction manual/booklet

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Netherlands; available across 32 countries total.

Country	On market since	Until
NetherlandsPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 00763000587802
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 0763000B000122279
Reference / catalog number: MMT-8401
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Device details

Quantity: 1
Additional product description: The Simplera Application, in combination with the Simplera Sensor, is intended for use only by patients and caregivers using a compatible mobile device and operating system, and who have sufficient experience to adjust mobile device audio and notification settings. The System is intended to communicate with digitally connected devices for the purpose of managing diabetes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Netherlands; available across 32 countries total.

Country	On market since	Until
NetherlandsPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Iceland	—	Still on market
Italy	—	Still on market
Liechtenstein	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Norway	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market
Türkiye	—	Still on market
XI	—	Still on market

MMT-8401

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Related devices

Certificates