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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

Saljol Wohnraumrollator WRXL… — Class I MDR by Saljol GmbH

MD Atlas
Saljol GmbH

EUDAMED last updated this device on Jul 21, 2023

Saljol Wohnraumrollator WRXL Ivory White

4058789SaljolWohnraumRE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Saljol GmbH
UDI-DI code: 04058789013052
Reference / catalog number: Saljol Wohnraumrollator WRXL Ivory White

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Manufacturer information

Organization name: Saljol GmbH
SRN: DE-MF-000015913
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.

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 Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04058789013052
Basic UDI-DI: 4058789SaljolWohnraumRE
Reference / catalog number: Saljol Wohnraumrollator WRXL Ivory White
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: The Indoor Rollator from Saljol is designed for indoor use and even floors. It supports people with balance or gait problems and contributes to increased mobility of disabled people. On the seat board the user can pause and move him- or herself around in a seated position.
Additional information URL: https://www.saljol.de/de/wohnraumrollator-handbremse/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y120609WALKING FRAMES WITH CHAIR, 4 WHEELS

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