Organization name

Evoluxion Health, Lda

SRN

PT-MF-000043932

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Portugal; available across 32 countries total.

Trade name

Bwave Rotating Bath Stool

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.

05600728191346

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.

5600728191BW150S3

Reference / catalog number

CB.CADE.8082

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

Purpose: Height-adjustable bath stool with swivelling seat and legs with non-slip suction cups for greater stability. Features: Anodized aluminium + PVC (Vinyl chloride) 4Non-sliptips Rotatingseat(Rotating360°) Adjustableinheight Maximum weight: Users up to 136 kg.

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.

• Y093303FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER

• Class I medical devices in EUDAMED

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