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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

MicroREC 3D — Class I MDR by Custom Surgical GmbH

MD Atlas
Custom Surgical GmbH

EUDAMED last updated this device on Apr 17, 2026

MicroREC 3D

426073827MRC3D9T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Custom Surgical GmbH
UDI-DI code: 04260738270427
Reference / catalog number: ZDN

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Manufacturer information

Organization name: Custom Surgical GmbH
SRN: DE-MF-000034959
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: MicroREC 3D
UDI-DI code: 04260738270427
Basic UDI-DI: 426073827MRC3D9T
Reference / catalog number: ZDN
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The MicroREC 3D is a digital stereoscopic imaging accessory designed to be used with compatible optical medical devices, such as surgical microscopes and slit-lamp biomicroscopes. The device is mounted to or integrated with the optical output of the primary device and enables stereoscopic digital visualization of the image produced by that device on an external display. It allows users to capture and record images and videos for documentation purposes. The MicroREC 3D operates as an accessory and relies on the primary optical device as the source of the image. The MicroREC 3D is intended to capture, display, and record stereoscopic digital images and videos derived from compatible optical medical devices. It is used to support stereoscopic visualization and documentation during examinations or procedures and functions as an accessory to the primary optical device.
Additional information URL: https://customsurgical.co/manuals/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC DEVICES - 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

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.

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