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Organization name
UDI-DI code
Reference / catalog number

0032117-004-012 — Class I MDR by DZO s.r.o.

MD Atlas
DZO s.r.o.

EUDAMED last updated this device on Sep 23, 2025

0032117-004-012

859405200111F9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DZO s.r.o.
UDI-DI code: 08594052002287
Reference / catalog number: 0032117-004-012

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Manufacturer information

Organization name: DZO s.r.o.
SRN: CZ-MF-000037146
Manufacturer status: Active

Related devices

0032125-001-009859405200333FVOn the market 0032117-002-070859405200111F9On the market 0032117-002-068859405200111F9On the market 0032117-002-064859405200111F9On the market 0032117-002-060859405200111F9On 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 Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594052002287
Basic UDI-DI: 859405200111F9
Reference / catalog number: 0032117-004-012
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: 011S růžová - metalická růžová
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: růžová, metalická růžová+tm.podešev
EU 29

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