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Organization name
UDI-DI code
Reference / catalog number

AUdiTE — Class IIa MDR by SINOVO health solutions…

MD Atlas
SINOVO health solutions GmbH

EUDAMED last updated this device on Nov 12, 2025

AUdiTE

PP03110DMS.2A.AD43

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SINOVO health solutions GmbH
UDI-DI code: 111954964558
Reference / catalog number: AUdiTE

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Manufacturer information

Organization name: SINOVO health solutions GmbH
SRN: DE-MF-000009832
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 12, 2025	Nov 12, 2027
Austria	Nov 12, 2025	Nov 12, 2027

Device identification

Trade name: not provided
UDI-DI code: 111954964558
Basic UDI-DI: PP03110DMS.2A.AD43
Reference / catalog number: AUdiTE
Issuing entity: IFA

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: AUdiTE is a software for diabetes management creating therapy recommendations
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040282GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.