Organization name

SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.

SRN

CN-MF-000013567

Manufacturer status

Active

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

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

• CW017

  When performing defibrillation, discharge as far as possible from electrodes, patches and any gel, cream or medicine on the chest of the patient. If there is a possibility that the defibrillator paddle could touch these materials, remove them from the patient. If the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient.

Primary placement in Germany; 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.

06970010880470

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.

697001088SVM-7521UP

Reference / catalog number

NA

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The bedside monitor is installed near a patient and displays the patient’s vital signs such as ECG, NIBP, SpO2, respiration and temperature, and generates alarms.

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.

• Z1203020201MULTI–PARAMETER PATIENT BEDSIDE MONITORS

• Class IIb medical devices in EUDAMED