Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

P-5907739314314 — Class I MDR by 4FIZJO GROUP SP. Z O. O.

MD Atlas
4FIZJO GROUP SP. Z O. O.

EUDAMED last updated this device on May 17, 2024

P-5907739314314

590773931PDMPMQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 4FIZJO GROUP SP. Z O. O.
UDI-DI code: 05907739314314
Reference / catalog number: P-5907739314314

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?

View device family (Basic UDI)

Manufacturer information

Organization name: 4FIZJO GROUP SP. Z O. O.
SRN: PL-MF-000031702
Manufacturer status: Active

Related devices

P-5907222931950590773931WALEKDOMASAZUSEOn the market P-5907739310590590773931WALEKDOMASAZUSEOn the market P-5907739314963590773931WALEKDOMASAZUSEOn the market P-5907739318107590773931ORTEZAUTOn the market P-5907739317889590773931ORTEZAUTOn 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.

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05907739314314
Basic UDI-DI: 590773931PDMPMQ
Reference / catalog number: P-5907739314314
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: Piłeczka do masażu punktowego - szara Piłki do masażu 4FIZJO zbudowane są z tworzywa sztucznego - pianki EPP (spieniony polipropylen) lub silikonu. Materiał jest wodoodporny, przez co wyrób jest łatwy do czyszczenia. Piłki są przeznaczone do automasażu, rozluźniania mięśni i rozluźniania punktów spustowych, oraz w celu poprawy czucia głębokiego, zwiększenia zakresu ruchu stawów, poprawie krążenia krwi w przebiegu neuropatii, rehabilitacji płaskostopia. Występujące modele różnią się rozmiarem i rodzajem (piłki pojedyncze i piłki podwójne), dzięki czemu można je dopasować do masażu poszczególnych części ciała.
Additional information URL: https://4fizjo.pl/product-pol-500-Pileczka-do-masazu-Lacrosse-Massage-Ball.html
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05907739314314

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120602PHYSIOTHERAPY EQUIPMENT

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

Become a partner of MD Atlas