Organization name

In2Bones, USA

SRN

US-MF-000023092

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW026

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 32 countries total.

Trade name

CoLink Afx

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.

00817906028560

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.

08101755025342

Reference / catalog number

P07 N1302

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

POSTEROLATERAL FIBULA PLATE,3-HOLE,RIGHT,TRIAL,Non-Sterile

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.

• L091104ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE

• Class IIa medical devices in EUDAMED

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