Organization name

ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA

SRN

BR-MF-000016681

Manufacturer status

Active

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

Primary placement in Austria; available across 32 countries total.

Trade name

PRESTIGE 1 H 3TM SG VP BV

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.

07899581341908

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.

78995813DentalUnitsXL

Reference / catalog number

16000004346

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

System composed of: Dental Chair New Croma Water Units Syncrus G3 Delivery Units Syncrus G3 H Dental Light Sirius G8 Sensor 5 LEDs

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.

• V08020101GENERIC USE ELECTRIC MEDICAL CHAIRS

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.