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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

KK34 — Class I MDR by ExamVision A/S

MD Atlas
ExamVision A/S

EUDAMED last updated this device on Feb 9, 2026

KK34

574400023EVLoupeXD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ExamVision A/S
UDI-DI code: 05744000230351
Reference / catalog number: KK34

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Manufacturer information

Organization name: ExamVision A/S
SRN: DK-MF-000032397
Manufacturer status: Active

Market distribution

Primary placement in Denmark; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05744000230351
Basic UDI-DI: 574400023EVLoupeXD
Reference / catalog number: KK34
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: ExamVision Loupe System Kepler Kompakt v2 3.4x (1 piece)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0316HELMETS AND BINOCULAR GLASSES FOR SURGEONS

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

ExamVision Loupe System Kepler Kompakt 3.5x574400023EVLoupeXDOn the market KK50574400023EVLoupeXDOn the market KK76574400023EVLoupeXDOn the market

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.