Organization name

RAM S.R.L.

SRN

IT-MF-000032751

Manufacturer status

Active

G407MSITS2300

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

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

• Consult instructions for use

  Consult instruction for use

• WARNING ACCIDENTALLY REBOOT SECURITY SYSTEM If the treadmill is stopped by one of the following operations: • Pushing the red emergency button down • Switching off the main power button • Pulling off the safety lanyard Wait at least 40 seconds Re-start the treadmill by one of the following operations: • Rotate and pull up on the red emergency button • Switch on the main power button • Replace the rubber cup of the safety lanyard

  OTHER

• WARNING To avoid interferences between equipment and devices, we recommend that the equipment be used at an adequate distance from such devices

  OTHER

Primary placement in Italy; available across 32 countries total.

Trade name

TREADMILL SPORT 870S

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.

G407MSITS2300

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.

++G407870treadmillsR9

Reference / catalog number

MSIT-S-230

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.

HIBCC

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

—

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.

• Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

• Class I medical devices in EUDAMED

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