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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

MonaOS 2 — Class IIa MDR by Clinomic Medical GmbH

MD Atlas
Clinomic Medical GmbH

EUDAMED last updated this device on Nov 20, 2024

MonaOS 2

42607357300199

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Clinomic Medical GmbH
UDI-DI code: 04260735730047
Reference / catalog number: MonaOS 2

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Manufacturer information

Organization name: Clinomic Medical GmbH
SRN: DE-MF-000013339
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Oct 20, 2023	Still on market
Romania	Jul 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260735730047
Basic UDI-DI: 42607357300199
Reference / catalog number: MonaOS 2
Issuing entity: GS1

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: Software as Medical Device
Additional information URL: https://www.clinomic.ai/ifu
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030201CENTRAL INFORMATION COMPUTING SYSTEMS

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

Related devices

Mona Terminal 2.0 series 0.14260735730029BOn the market Mona Terminal 1.1 series 0.34260735730029BOn the market Mona Terminal 1.1 series 0.24260735730029BOn the market Mona Terminal 1.1 series 0.14260735730029BOn the market MonaOS 34260735730039DOn 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.