Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

4262516560003 — Class I MDR by Carealytix Digital…

MD Atlas
Carealytix Digital Health GmbH

EUDAMED last updated this device on Mar 5, 2025

4262516560003

426251656MIZUDL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Carealytix Digital Health GmbH
UDI-DI code: 04262516560003
Reference / catalog number: 4262516560003

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Carealytix Digital Health GmbH
SRN: DE-MF-000045266
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: 04262516560003
Basic UDI-DI: 426251656MIZUDL
Reference / catalog number: 4262516560003
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: Mizu helps patients suffering from different stages of chronic kidney disease (CKD), end-stage renal disease, or kidney transplant recipients to calculate their BMI for personalized disease management. The application supports patients in understanding the importance of their current body composition based on their disease stage by providing a BMI calculator (calculation of BMI based on height and weight input), educating patients on proposed target corridors for their current disease stage, and improving self-management by helping patients understand what they can do themselves to optimize their personal BMI based on calculated values. Mizu is not intended for diagnosis, treatment, or medical decision-making but serves as a patient-centered support tool for disease management.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

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.