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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

4262432420009 — Class I MDR by Oska Health Medical GmbH

MD Atlas
Oska Health Medical GmbH

EUDAMED last updated this device on Aug 14, 2023

4262432420009

426243242OSKA9H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oska Health Medical GmbH
UDI-DI code: 04262432420009
Reference / catalog number: 4262432420009

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Manufacturer information

Organization name: Oska Health Medical GmbH
SRN: DE-MF-000036511
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: 04262432420009
Basic UDI-DI: 426243242OSKA9H
Reference / catalog number: 4262432420009
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: Oska supports the doctor prescribed therapy of people with CKD (Chronic Kidney Disease). It helps to alleviate the complications of CKD and improves patient self management, by helping people to learn about their condition and understand what they can do themselves to support their condition. The application is geared to personal use at home (not for monitoring of data by the treating physician).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12099092VARIOUS NEPHROLOGY AND HAEMODIALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

04262432420016426243242OSKACMDFVOn 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.