Organization name

YAHORNG ELECTRONIC CO., LTD.

SRN

TW-MF-000010109

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 18 countries total.

Trade name

GARMIN

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.

04719873310098

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.

471987331BP2021A8G

Reference / catalog number

190-02770-90_0A

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Smart blood pressure monitor

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.

• Z1203020501NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

• Class IIa medical devices in EUDAMED

This device is not currently linked to any other device.

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

Certificate health across this manufacturer's portfolio.