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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

4260685531084 — Class I MDR by Besco Medical Medizin-…

MD Atlas
Besco Medical Medizin- und Rehaprodukte GmbH

EUDAMED last updated this device on Dec 23, 2024

4260685531084

4260685531000X9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Besco Medical Medizin- und Rehaprodukte GmbH
UDI-DI code: 42606855310842
Reference / catalog number: 4260685531084

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Manufacturer information

Organization name: Besco Medical Medizin- und Rehaprodukte GmbH
SRN: DE-MF-000008152
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 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: 42606855310842
Basic UDI-DI: 4260685531000X9
Reference / catalog number: 4260685531084
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: Der Rollator erweitert Ihre Mobilität bei Einschränkungen in der Gehfähigkeit. Er ist für die Anwendung auf ebenem Untergrund im Innenbereich vorgesehen. Der IR10+ ist besonders leicht und lässt sich gut in Innenräumen manövrieren. Mit Hilfe des Tabletts können Sie im Haushalt kleinere Gegenstände transportieren, ohne auf die Sicherheit und Unterstützung des Rollators verzichten zu müssen. Sie können sich jederzeit hinsetzen (Tablett vorher entfernen) und ausruhen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y120606WHEELED WALKER

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.