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

85292801 — Class I MDR by Polifoam Műanyagfeldolgo…

MD Atlas
Polifoam Műanyagfeldolgozó Kft.

EUDAMED last updated this device on May 17, 2023

85292801

59976085WellsteppME

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Polifoam Műanyagfeldolgozó Kft.
UDI-DI code: 05997608500009
Reference / catalog number: 85292801

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: Polifoam Műanyagfeldolgozó Kft.
SRN: HU-MF-000035390
Manufacturer status: Inactive

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05997608500009
Basic UDI-DI: 59976085WellsteppME
Reference / catalog number: 85292801
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: Thanks to its beach-themed shapes and pleasant surface, the WellStepp Kids development mat makes strengthening children's soleus muscles a fun game. Its special design provides a comfortable and effective solution for the prevention of lifelong orthopaedic disorders in childhood. Regular use can prevent flat feet and other foot joint problems, help maintain healthy posture and promote proper development of the nervous system.
Additional information URL: https://www.wellstepp.eu/
Clinical sizes: 58 MU10
154 MU10

EMDN nomenclature code(s)

Y0599LEARNING AND TRAINING DEVICES - OTHER

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.