Organization name

SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.

SRN

CN-MF-000013567

Manufacturer status

Active

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.

06970010881385

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.

697001088WS-710PE4

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The WS-710P recorder module is for the SVM-7100 series vital signs monitor. The recorder module can record the waveform data of the patients’ vital signs and print this data through communication with the 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.

• Z1203020280MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

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