Organization name

Wuxi Beien Surgery Device Co., Ltd.

SRN

CN-MF-000017684

Manufacturer status

Active

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

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

• CW011

  /

Primary placement in Türkiye; available across 32 countries total.

Trade name

Disposable Endoscopic Stapler Reload Unit

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.

06971767870936

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.

69717687MANUAL4K

Reference / catalog number

MANUAL

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

Refer to IFU

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.

• H020201010101SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY
• H020301040199SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY - OTHER

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.