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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

MSOT Frontier — Class IIa MDR by iThera Medical GmbH

MD Atlas
iThera Medical GmbH

EUDAMED last updated this device on Jul 11, 2025

MSOT Frontier

4262380070204TX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iThera Medical GmbH
UDI-DI code: 04262380070028
Reference / catalog number: SYS-MSOTFrontier

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Manufacturer information

Organization name: iThera Medical GmbH
SRN: DE-MF-000010082
Manufacturer status: Inactive

Critical warnings

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

CW014
Type BF Applied Part
CW013
Warning: Visible and Invisible Laser Radiation
CW010
Consult Instructions for Use
CW011
Caution, General
CW167
Wear protective eyewear
CW258
Warning: Hot Surface
CW257
Warning for Trapping zones

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: MSOT Frontier
UDI-DI code: 04262380070028
Basic UDI-DI: 4262380070204TX
Reference / catalog number: SYS-MSOTFrontier
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: A mobile assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging. It includes a processing unit with a monitor, controls, integrated software, and a dedicated laser-emitting extracorporeal ultrasound transducer. Pulsed near-infrared laser light of various wavelengths is emitted and the associated acoustic feedback (photoacoustic effect) provides complementary information regarding tissue composition/functionality based on the presence of endogenous chromophores, such as hemoglobin; this photoacoustic data can be overlaid on the associated US image.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11039099VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER

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

MSOT Acuity Echo4262380070203TVOn 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.