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

  Refer to instruction manual.

Primary placement in Germany; available across 32 countries total.

Trade name

Headgear

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.

06903053037945

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.

69449040AB0200002947

Reference / catalog number

RA15304

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

1

Additional product description

The product is intended for securing the Headgear/Bonnet to the patient's head.

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.

• R030180RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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