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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

Levacare — Class I MDR by ISKO KOCH GmbH

MD Atlas
ISKO KOCH GmbH

EUDAMED last updated this device on Oct 5, 2022

Levacare

42518585KR-100-D8Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ISKO KOCH GmbH
UDI-DI code: 04251858500020
Reference / catalog number: KR-100-D

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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: Levacare
UDI-DI code: 04251858500020
Basic UDI-DI: 42518585KR-100-D8Y
Reference / catalog number: KR-100-D
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 standing device is used exclusively for standing training for people who are unable to walk or have difficulty walking for independent use with an assistant. Standing training is used in inpatient and outpatient rehabilitation, as well as in the home environment. The design of our standing devices enables independent, stable and safe standing. An electrical belt retractor is used to move the patient from the wheelchair to a secured standing position.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y050202STANDING FRAMES

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

Related devices

Levacare42518585KR-100-B8UOn the market Levacare Pro42518585KR-111-B98On the market Levacare Pro42518585KR-111-D9COn the market SI-011-142518585SI-011-17UOn the market

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.