Organization name

WUHAN MINDRAY SCIENTIFIC CO., LTD.

SRN

CN-MF-000032692

Manufacturer status

Active

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

• CW011

  The use of the device must be selected by a qualified orthopedic surgeon based on the patient's condition. Due to the wide variety of products for fixation of fractures, it is necessary to select the fracture internal fixation instruments according to ensure the correct operation.

Primary placement in Germany; available across 32 countries total.

Trade name

Torque Indicating Handle 0.4N.m

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.

06934635734730

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.

B-06934635734730

Reference / catalog number

F16BB-PA01004

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

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.

• L098002ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE

• Class I medical devices in EUDAMED

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