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.

• Caution

  Follow the instructions for use and adhere to all warnings and cautions.

Primary placement in Germany; available across 32 countries total.

Trade name

SmartTemp Probe Cover

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.

06944904007908

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.

69449040AB010000433G

Reference / catalog number

ST-001(M09A-30-62128)

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 I

Applicable legislation

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

Status

On the market

Quantity

10

Additional product description

—

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.

• T030102COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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