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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

SK2012m — Class I MDR by Monoqool

MD Atlas
Monoqool

EUDAMED last updated this device on May 21, 2026

SK2012m

57400206SLD1008Z

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Monoqool
UDI-DI code: 05740020607302
Reference / catalog number: SK2012m

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Manufacturer information

Organization name: Monoqool
SRN: DK-MF-000025532
Manufacturer status: Active

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Jan 1, 2016	Jan 1, 2099

Device identification

Trade name: not provided
UDI-DI code: 05740020607302
Basic UDI-DI: 57400206SLD1008Z
Reference / catalog number: SK2012m
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: Slider series eyewear. Spike SK2012m model
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02100203METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES

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.