Organization name

ANTAR MEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

SRN

PL-MF-000001583

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Nie stosować u użytkowników o masie ciała powyżej 150 kg, niezdolnych do samodzielnego utrzymania pozycji siedzącej lub z poważnymi zaburzeniami świadomości albo orientacji. Nie używać wyrobu, jeżeli jest uszkodzony, niestabilnie zamontowany lub mechanizm podnoszenia działa nieprawidłowo. Nie obsługiwać urządzenia mokrymi rękami ani narażać jego połączeń elektrycznych na bezpośredni kontakt z wodą. Nie wkładać przedmiotów do ruchomych części i nie dopuszczać do wciągnięcia odzieży przez mechanizm.

  OTHER

• Do not use in users weighing more than 150 kg, users unable to maintain a seated position independently, or users with serious disturbances of consciousness or orientation. Do not use the device if it is damaged, improperly or unstably installed, or if the lifting mechanism is malfunctioning. Do not operate the device with wet hands or expose its electrical connections to direct contact with water. Do not insert objects into moving parts and prevent clothing from being drawn into the mechanism.

  OTHER

Primary placement in Poland; available across 32 countries total.

Trade name

NASADKA TOALETOWA PODWYŻSZAJĄCA, ELEKTRYCZNA, WSPIERAJĄCA WSTAWANIE

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05901571477909

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

59015714AT512113U

Reference / catalog number

AT51211

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The electric raised toilet seat is intended to assist persons with reduced mobility when sitting down on and standing up from the toilet by controlled lifting and lowering of the user.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Y091215TOILET SEATS, RAISED

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.