Organization name

iFIT Prosthetics

SRN

US-MF-000032928

Manufacturer status

Active

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

• Consult instructions for use

  Refer to instructions for fitting guide, warnings and indications

Primary placement in XI; available across 32 countries total.

Trade name

iFIT Prosthesis

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.

00850049686143

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.

0850049686TT200i64

Reference / catalog number

TT200Ni

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

International KIT - Transtibial prosthetic device, Narrow, Buckles only on right

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 20–28 MU10

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

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

• Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)

• Class I medical devices in EUDAMED

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