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Organization name
UDI-DI code
Reference / catalog number

5999884370017 — Class I MDR by Ergo-Prevent Kft.

MD Atlas
Ergo-Prevent Kft.

EUDAMED last updated this device on Aug 27, 2024

5999884370017

5999884370genova7M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ergo-Prevent Kft.
UDI-DI code: 05999884370017
Reference / catalog number: 5999884370017

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Manufacturer information

Organization name: Ergo-Prevent Kft.
SRN: HU-MF-000042772
Manufacturer status: Active

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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.

Market distribution

Primary placement in Hungary; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05999884370017
Basic UDI-DI: 5999884370genova7M
Reference / catalog number: 5999884370017
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: —
Additional information URL: https://www.ergoprevent.hu/
Clinical sizes: S

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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
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Software identification