Organization name

Well Lead Medical Co., Ltd.

SRN

CN-MF-000006728

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

Welllead Dcisposable Air Cushion Face Mask

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.

06936881190186

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.

69449327FA07A01DA

Reference / catalog number

FA07A050010

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Disposable Air Cushion Face Mask is used for clinical anesthesia assisted breathing and cardiopulmonary resuscitation auxiliary.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Neonate

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R03010101ANAESTHETIC FACE MASKS

• Class IIa medical devices in EUDAMED

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