Organization name

In2Bones SAS

SRN

FR-MF-000005246

Manufacturer status

Active

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

• Consult instructions for use
• Do not use if package is damaged
• Do not re-use
• Do not resterilize

Primary placement in Belgium; available across 31 countries total.

Trade name

AKILINK

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.

03760225718322

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.

B-03760225718322

Reference / catalog number

G03 10001

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

AKILINK MINI INVASIVE ACHILLES TENDON REPAIR SYSTEM

Additional information URL

https://eifu.conmed.com/eifu/

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.

• P091399ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

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