Organization name

Ambutech Inc.

SRN

CA-MF-000003389

Manufacturer status

Active

G027PGS4061

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

Primary placement in Austria; available across 32 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.

G027PGS4061

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.

++G027MbId017N

Reference / catalog number

PGS4061

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

• 30–190 MU10

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

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

• Y120303WHITE STICKS FOR BLIND PERSONS

• Class I medical devices in EUDAMED

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