Organization name

IMPLANT PROTESIS DENTAL 2004 S.L.

SRN

ES-MF-000002195

Manufacturer status

Active

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

Primary placement in Spain; available across 23 countries total.

Trade name

Custom Ti Base Non-Engaging GM H 1.0

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.

08435566621628

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.

8435566603BQ

Reference / catalog number

IPD/RB-IR-01/3D

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://ipd2004.com/en/ifu

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.

• Q01020602COMBINED DENTAL PROSTHESES

• Class IIb medical devices in EUDAMED