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Organization name
UDI-DI code
Reference / catalog number

Klinikbett IMPULSE KL Edition 300 — Class I MDR by Malsch GmbH

MD Atlas
Malsch GmbH

EUDAMED last updated this device on Oct 4, 2023

Klinikbett IMPULSE KL Edition 300

4065848MALSCH-PKL00002V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Malsch GmbH
UDI-DI code: 04065848000168
Reference / catalog number: 000017

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Manufacturer information

Organization name: Malsch GmbH
SRN: DE-MF-000005173
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: Klinikbett IMPULSE KL Edition 300
UDI-DI code: 04065848000168
Basic UDI-DI: 4065848MALSCH-PKL00002V
Reference / catalog number: 000017
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: Our IMPULSE KL hospital bed is equipped with a comprehensive range of basic features which can be extended flexibly to suit every need. The use of high-quality materials guarantees outstanding stability despite the low net weight. The high processing quality enables a safe working load of up to 300 kg and provides operators with durability and long-term planning security. Its aesthetic design with sealed, homogeneous surfaces supports easy cleaning and disinfection. An intuitive staff controller ensures quick access to the function keys and enables patient-specific functions to be released for adjustment positions. Diverse fixtures and fittings such as bed exit warning system, low positioning, radiolucent back rest, brake alarm etc. offer solutions for specific needs and application scenarios to simplify daily ward routines.
Additional information URL: https://bettenmalsch.com/de/klinik-und-psychiatriebetten/vollmotorisches-klinikbett-impulse-kl.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08060101HOSPITAL/HOME CARE ELECTRIC MEDICAL BEDS

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.