Organization name

UNION DENTAL S.A.

SRN

ES-MF-000003189

Manufacturer status

Active

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

Primary placement in Spain; available across 32 countries total.

Trade name

ELEPHANDENS

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.

08435288485607

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.

084352884UD-TEETHVS

Reference / catalog number

M8A3M42S

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

ELEPHANDENS Posterior Teeth, Shade A3, Mould M42 up.

Additional information URL

https://unidesa-odi.com/descargas/

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.

• Q01020605TEMPORARY DENTAL PROSTHESES
• Q01020603SKELETAL DENTAL PROSTHESES
• Q01020602COMBINED DENTAL PROSTHESES
• Q01020601MOBILE DENTAL PROSTHESES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.