Organization name

EUROTEKNIKA

SRN

FR-MF-000004032

Manufacturer status

Active

Primary placement in France; available across 21 countries total.

Trade name

not provided

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.

03700977513110

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.

37009775scanbody3Z

Reference / catalog number

ETK_UN.SBPS

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

Scanbody Slim TETRA - multi is the device model associated with the Reference/Catalogue number ETK_UN.SBPS

Additional information URL

https://ifu.lyra.dental/

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.