Organization name

Advantech Co., Ltd.

SRN

TW-MF-000029374

Manufacturer status

Active

Primary placement in Netherlands; available across 15 countries total.

Trade name

Computer

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.

04719879827613

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.

471987982POC-621-12RZ

Reference / catalog number

POC-621-12, POC62112

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The POC-621 SERIES is intended to serve as a Point-of-Care terminal for integration with hospital systems. POC-621 SERIES is designed for general purpose medical computing in the hospital environment, for data collection and for displaying information. It should not be used as a life-support system.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Y210999PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER

• Class I medical devices in EUDAMED

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