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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

Beamsplitter — Class I MDR by Custom Surgical GmbH

MD Atlas
Custom Surgical GmbH

EUDAMED last updated this device on Sep 8, 2023

Beamsplitter

426073827BSXHU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Custom Surgical GmbH
UDI-DI code: 04260738270298
Reference / catalog number: BSZ

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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: Beamsplitter
UDI-DI code: 04260738270298
Basic UDI-DI: 426073827BSXHU
Reference / catalog number: BSZ
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: PRODUCT DESCRIPTION: The Beamsplitter is an optical hardware device to be attached to microscopic equipment allowing light to redirect to the MicroREC optical system. It has different models to fit a variety of microscopic equipment manufacturers. INTENDED USE: The Beamsplitter is designed to fit surgical microscopes and slit lamps to split light and redirect it to the MicroREC system. This product is not intended to connect binocular viewers.
Additional information URL: No additional information URL provided by the manufacturer.
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

Related devices

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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.