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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

LHDI26A — Class I MDR by KOBA Vision

MD Atlas
KOBA Vision

EUDAMED last updated this device on Feb 28, 2023

LHDI26A

PP12092VOCATEX409

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KOBA Vision
UDI-DI code: 1312092LHDI26A007
Reference / catalog number: LHDI26A

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Manufacturer information

Organization name: KOBA Vision
SRN: BE-MF-000000212
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 1312092LHDI26A007
Basic UDI-DI: PP12092VOCATEX409
Reference / catalog number: LHDI26A
Issuing entity: IFA

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: Video magnifier to magnify text for the visually impaired
Additional information URL: https://www.kobavision.be/hulpmiddelen-slechtzienden-blinden/beeldschermloepen-zonder-voorleesfunctie/koba-vision-iris-27-beeldschermloep/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y210603VIDEO MAGNIFIERS

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.