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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

394435667211 — Class I MDR by KALEOS EYEHUNTERS SLU

MD Atlas
KALEOS EYEHUNTERS SLU

EUDAMED last updated this device on Mar 5, 2024

394435667211

84356672394435667211C3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KALEOS EYEHUNTERS SLU
UDI-DI code: 84356672394435667211C3
Reference / catalog number: 394435667211

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Manufacturer information

Organization name: KALEOS EYEHUNTERS SLU
SRN: ES-MF-000039443
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 84356672394435667211C3
Basic UDI-DI: 84356672394435667211C3
Reference / catalog number: 394435667211
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02100202PLASTIC 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

Related devices

3944356672184356672394435667214C9On the market 39443566721284356672394435667212C5On the market 39443566721384356672394435667213C7On 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.