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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

010-260-2.0.1 — Class IIb MDR by Dr. Sennewald…

MD Atlas
Dr. Sennewald Medizintechnik GmbH

EUDAMED last updated this device on Nov 26, 2025

010-260-2.0.1

PP12868SIGMAVISION33

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Sennewald Medizintechnik GmbH
UDI-DI code: 1312868SIGMAVISION-2.0.X063
Reference / catalog number: 010-260-2.0.1

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Manufacturer information

Organization name: Dr. Sennewald Medizintechnik GmbH
SRN: DE-MF-000007093
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 1312868SIGMAVISION-2.0.X063
Basic UDI-DI: PP12868SIGMAVISION33
Reference / catalog number: 010-260-2.0.1
Issuing entity: IFA

Classification

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

Device details

Quantity: 1
Additional product description: Software for MR Thermometry
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12039092VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE

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

010-260-DONGLEPP12868SIGMAVISION33On 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.