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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

Lens Reviewer — Class I MDD by AkknaTek

MD Atlas
AkknaTek

EUDAMED last updated this device on May 16, 2024

Lens Reviewer

B-42624749300045

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AkknaTek
UDI-DI code: 42624749300045
Reference / catalog number: LR04

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Manufacturer information

Organization name: AkknaTek
SRN: DE-MF-000025855
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: Lens Reviewer
UDI-DI code: 42624749300045
Basic UDI-DI: B-42624749300045
Reference / catalog number: LR04
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Non-contact optical imaging system for cataract treatment
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120113OPHTHALMOMETERS

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

This device is not currently linked to any other device.

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.