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.

• CW011

  The instruction manual/booklet must be read.

Primary placement in Belgium; available across 12 countries total.

Trade name

Single-use Flexible Video Bronchoscope

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.

06974235401212

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.

697423540DBRS2FZ

Reference / catalog number

DBRS2-303HP

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

Enhanced version, high-definition, with suction button. Module Model:1, Working Channel:3mm, Maximum insertion portion width:6.3mm.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 6.3 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12020802VIDEO BRONCHOSCOPES

• Class IIa medical devices in EUDAMED

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