Organization name

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

SRN

CN-MF-000014156

Manufacturer status

Active

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

• CW011

  please see the IFU

Primary placement in Germany; available across 32 countries total.

Trade name

Wash Buffer

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.

06903053077453

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.

69449040AB74000505K

Reference / catalog number

105-046470-00

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

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Wash Buffer

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.

• W01029003BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

• IVDR Class A medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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