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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

503001 — Class I MDR by Volter s.r.o.

MD Atlas
Volter s.r.o.

EUDAMED last updated this device on Jul 19, 2024

503001

859421717xRoverREHA_str6Z

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Volter s.r.o.
UDI-DI code: 08594217170004
Reference / catalog number: 503001

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Manufacturer information

Organization name: Volter s.r.o.
SRN: CZ-MF-000041158
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08594217170004
Basic UDI-DI: 859421717xRoverREHA_str6Z
Reference / catalog number: 503001
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: monolithic alu construction, 5points safety belt, fixation insert, canopy, rear bag, rear plastic 20" wheels with drum brakes and park lock, swivel front wheel 6" with plastic fork, retaining belt, metal handlebar joint TH900/TH88
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y122103PUSH WHEELCHAIRS

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

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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.