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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

OneTwo Diabetes — Class I MDD by OneTwo Analytics AB

MD Atlas
OneTwo Analytics AB

EUDAMED last updated this device on May 22, 2026

OneTwo Diabetes

B-07350158330065

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OneTwo Analytics AB
UDI-DI code: 07350158330065
Reference / catalog number: 07350158330065

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View device family (Basic UDI)

Manufacturer information

Organization name: OneTwo Analytics AB
SRN: SE-MF-000049462
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	May 6, 2024	Still on market

Device identification

Trade name: OneTwo Diabetes
UDI-DI code: 07350158330065
Basic UDI-DI: B-07350158330065
Reference / catalog number: 07350158330065
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Software as a Medical Device for healthcare professionals to analyze and visualize continuous glucose monitoring data for diabetes management support.
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)07350158330065

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EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

OneTwo InsightsB-07350158330041On the market OneTwo Insights735015833INSIGHTS43On the market PRIO735015833PRIOEMOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.