Organization name

Tria Spine Medikal A.Ş.

SRN

TR-MF-000017385

Manufacturer status

Active

Primary placement in Türkiye; available across 32 countries total.

Trade name

Cranio Square Plate, 4 holes, length 10mm 0.6mm thickness

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.

08682408134192

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.

B-08682408134192

Reference / catalog number

TH-02-023

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Cranio Square Plate, 4 holes, length 10mm 0.6mm thickness

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Cranio Square Plate, 4 holes, length 10mm 0.6mm thickness

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P09120503OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

• Class IIb medical devices in EUDAMED

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