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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

000015 — Class I MDR by Malsch GmbH

MD Atlas
Malsch GmbH

EUDAMED last updated this device on Oct 4, 2023

000015

4065848MALSCH-PKL00002V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Malsch GmbH
UDI-DI code: 04065848000144
Reference / catalog number: 000015

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Manufacturer information

Organization name: Malsch GmbH
SRN: DE-MF-000005173
Manufacturer status: Active

Related devices

Care bed AURA4065848MALSCH-PKL00002VOn the market Care bed AURA Edition LR4065848MALSCH-PKL00002VOn the market Care bed AYEEN Edition 400 N4065848MALSCH-PKL00002VOn the market Care bed AYLEEN Edition 4004065848MALSCH-PKL00002VOn the market Care bed AYLEEN Edition 400 HC4065848MALSCH-PKL00002VOn the market

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: 04065848000144
Basic UDI-DI: 4065848MALSCH-PKL00002V
Reference / catalog number: 000015
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: All four editions of the basic AYLEEN care bed feature maintenance-free linear drives and a reliable low-voltage control electronics for safe and stable height adjustment. The four-part, electrically adjustable reclining surface has an automatic comfort function to contour the reclining surface (auto contour) in addition to the individual adjustment of the back rest, upper and lower leg supports. This enables the bed occupant to move into a comfortable, upright position quickly and easily.
Additional information URL: https://bettenmalsch.com/de/pflegebetten/basis-pflegebett-ayleen.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

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.