Organization name

AMBELIO

SRN

FR-MF-000001631

Manufacturer status

Active

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

• CW010

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Primary placement in France; available across 32 countries total.

Trade name

KIT KNEEFREEZ PO

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.

03770008904248

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.

3770008904KNEEFREEZPO00AA

Reference / catalog number

-

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

Le kit KNEEFREEZ PO est composé d’une genouillère ligamentaire articulée avec 4 poches de cryothérapie FREEZSNOW (2 poches rondes et 2 poches rectangles). Son système de fermeture par bandes auto agrippantes permet d’ajuster la genouillère à la taille du patient. TA

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.

• Y061209KNEE ORTHOSES

• Class I medical devices in EUDAMED

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