Organization name

Shenzhen Yimi Life Technology Co., Ltd

SRN

CN-MF-000029928

Manufacturer status

Active

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

• CW011

  Refer to the user manual

Primary placement in Germany; available across 12 countries total.

Trade name

Pulse Oximeter

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.

06972911370302

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.

697291137YH3Y

Reference / catalog number

YH01

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

This Pulse Oximeter is intended for spot check or continuous measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR) of adult or pediatric patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

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.

• Z1203020408PULSE OXIMETERS

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.