Organization name

Alps South, LLC

SRN

US-MF-000001260

Manufacturer status

Active

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

• P332 – If skin irritation occurs: P313 – Get medical advice/attention.
• • The material will delaminate if it comes into contact with oily substances. Avoid petroleum jelly and other oil-based lubricant on the skin. Wash the liner/sleeve with a hypoallergenic pH-balanced soap; do not use oil-based soap. Do not soak in acetone or you will dissolve the gel. • Do not wear on injured skin or open wounds. Protect the injured area with a suitable device before wearing the liner /sleeve.

  OTHER

Primary placement in Italy; available across 20 countries total.

Trade name

3mm Cushion Casting Liner Set

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.

00713980004301

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.

0713980100010056Z

Reference / catalog number

CGPFR-3MM

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

—

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.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

• Class I medical devices in EUDAMED

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