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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

25220 — Class I MDR by ORTOSERVIS s.r.o.

MD Atlas
ORTOSERVIS s.r.o.

EUDAMED last updated this device on May 18, 2026

25220

859420944001JM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOSERVIS s.r.o.
UDI-DI code: 08594209440016
Reference / catalog number: 25220

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Manufacturer information

Organization name: ORTOSERVIS s.r.o.
SRN: CZ-MF-000003866
Manufacturer status: Active

Related devices

Rollator with support platform Stabilo859420944002JPOn the market 20530859420944003JROn the market 20531859420944003JROn the market 20532859420944004JTOn the market 20533859420944004JTOn 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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW999
Kontraindikace: Osoby se sníženou mentální schopností chápat rizika spojená s používáním hrazdy, osoby s hmotností nad 120 kg, osoby s nedostatečnou funkcí horních končetin.

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: 08594209440016
Basic UDI-DI: 859420944001JM
Reference / catalog number: 25220
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: Zdravotnický prostředek (samostojná hrazda s madlem) je určen jako pomůcka pro osoby se sníženou pohyblivostí. Zamýšlený účel použití je usnadnit uživateli pohyb na lůžku včetně usnadnění vstávání z něj a usnadnit vstávání a přesun ze sedacího nábytku (židle, křeslo, pohovka). Hrazda je konstruována tak, aby nemusela být u lůžka či nábytku jakkoliv připevněna. Prostředek může používat uživatel-laik pro jeho zamýšlený účel použití.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08068099MEDICAL BEDS - OTHER ACCESSORIES

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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Software identification