Organization name

Himaging Technology (Shanghai) Co., Ltd.

SRN

CN-MF-000028002

Manufacturer status

Active

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

• CW010

  The instruction manual/booklet must be read.

Primary placement in Belgium; available across 11 countries total.

Trade name

Single-Use Flexible Video Cystoscope

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.

06974235401021

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.

697423540DCYSKX

Reference / catalog number

DCYS-100HLP

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

DCYS-100HLP single-use sterile flexible video cystoscope integrates high-definition CMOS image sensor, LED lighting and Himaging GRS imaging technology, independent working channel and suction channel. It supports functions such as 240 ° rotation of the insertion portion, left and right hand configuration.

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.

• Z12020711VIDEO CYSTOURETHROSCOPES

• Class IIa medical devices in EUDAMED

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