Organization name

Biotech Dental

SRN

FR-MF-000000669

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not use if package is damaged
• Do not use past indicated date

Primary placement in France; available across 30 countries total.

Trade name

Kontact W

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.

03701045220817

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.

3701045299974V3

Reference / catalog number

WPSCANPA6

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

I6-Scanbody for KW implant

Additional information URL

https://ifu.biotech-dental.com/

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.

• Q010207DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY

• Class I medical devices in EUDAMED

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