056-033

Organization name

Great Lakes Dental Technologies

SRN

US-MF-000003408

Manufacturer status

Active

+D7750560331

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

Primary placement in Germany; available across 15 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.

+D7750560331

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.

++D77505602387

Reference / catalog number

056-033

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.

HIBCC

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU50

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

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

• Q010503IMPRESSION MATERIAL TRAYS, SINGLE-USE

• Class I medical devices in EUDAMED

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