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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

SI-011-1 — Class I MDR by ISKO KOCH GmbH

MD Atlas
ISKO KOCH GmbH

EUDAMED last updated this device on May 5, 2022

SI-011-1

42518585SI-011-17U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ISKO KOCH GmbH
UDI-DI code: 04251858503151
Reference / catalog number: SI-011-1

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Manufacturer information

Organization name: ISKO KOCH GmbH
SRN: DE-MF-000010081
Manufacturer status: Active

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: 04251858503151
Basic UDI-DI: 42518585SI-011-17U
Reference / catalog number: SI-011-1
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: Das Rotadorm Care ist das bewährte Pflegebett mit integrierter Aufstehfunktion von ISKOmed. Mit seiner hohen Funktionalität bringt dieses eingetragene Hilfsmittel sowohl den Patienten als auch den Pflegenden Unterstützung und Erleichterung im Alltag.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080699MEDICAL BEDS - OTHER

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.