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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

V12400-01 — Class IIa MDR by Munich Surgical Imaging…

MD Atlas
Munich Surgical Imaging GmbH

EUDAMED last updated this device on May 21, 2026

V12400-01

4064434SeeLumaiOCTBT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Munich Surgical Imaging GmbH
UDI-DI code: 04064434000179
Reference / catalog number: V12400-01

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Manufacturer information

Organization name: Munich Surgical Imaging GmbH
SRN: DE-MF-000009644
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 23, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04064434000179
Basic UDI-DI: 4064434SeeLumaiOCTBT
Reference / catalog number: V12400-01
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: The medical device is intended to intraoperatively acquire optical coherence tomography (OCT) data of the anterior and the posterior segment of the eye. It provides OCT data, can be controlled via an interface, and enables the application of OCT functionality to a surgical microscope.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120121OPTICAL CONSISTENCY TOMOGRAPHS

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.