Organization name

Well Lead Medical Co., Ltd.

SRN

CN-MF-000006728

Manufacturer status

Active

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

• CW999

  Patients who are allergic to plastics are not recommended to use the Cannula.

Primary placement in Germany; available across 32 countries total.

Trade name

Welllead ETCO2 Sampling Cannula

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.

06944932751736

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.

69449327FR01B02K4

Reference / catalog number

R01B02013Y

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

ETCO2 Sampling Cannula is intended for carbon dioxide sampling when mainstream capnography is used. Clinical applications of Capnography can be divided into six major categories: Airway, Breathing, Circulation, Anesthetic Delivery Apparatus, Homeostasis and Nonperioperative.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• With Filter Adult

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

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

• R0301020301OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)

• Class IIa medical devices in EUDAMED

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