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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 — Class I MDR by Custom Surgical GmbH

MD Atlas
Custom Surgical GmbH

EUDAMED last updated this device on Aug 11, 2023

MicroREC

426073827MRCJ6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Custom Surgical GmbH
UDI-DI code: 04260738270281
Reference / catalog number: MRC

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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
UDI-DI code: 04260738270281
Basic UDI-DI: 426073827MRCJ6
Reference / catalog number: MRC
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 MicroREC is an optical hardware device to record microscope procedures with the smartphone. It has a body made of aluminum and lenses to capture the image from the microscope and display it in the smartphone. It has two Adapters to fit with specific brands. INTENDED USE: The MicroREC is designed to fit surgical microscopes and slit lamps to capture the image with a smartphone. The two adapters allow MicroREC to be attached in different microscopes and slit lamps.
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

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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.