Organization name

Hopper

SRN

FR-MF-000024280

Manufacturer status

Active

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

• Consult healthcare professional before use
• Consult instructions for use
• Do not cut

Primary placement in France; available across 32 countries total.

Trade name

Outsider by Hopper TM-A

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.

03770027689249

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.

3770027689HP012T

Reference / catalog number

HP01TM-A

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 Outsider by Hopper foot is a medical device intended for the prosthetic fitting of individuals with lower-limb amputations. It is designed to provide a versatile solution combining energy return, comfort, and stability, enabling users to engage in a wide range of physical activities while remaining suitable for an active daily lifestyle.

Additional information URL

https://hopper-accessibility.com/produit/outsider-foot/

Clinical sizes

• 66–80 MU29

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

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

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

• Class I medical devices in EUDAMED

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