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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

39443566721 — Class I MDR by KALEOS EYEHUNTERS SLU

MD Atlas
KALEOS EYEHUNTERS SLU

EUDAMED last updated this device on Mar 5, 2024

39443566721

84356672394435667214C9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KALEOS EYEHUNTERS SLU
UDI-DI code: 84356672394435667214C9
Reference / catalog number: 39443566721

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Manufacturer information

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

Related devices

39443566721184356672394435667211C3On 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.

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: 84356672394435667214C9
Basic UDI-DI: 84356672394435667214C9
Reference / catalog number: 39443566721
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)

Q02100201METAL 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

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Expiration date
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