HPE15018KT0030GI

Organization name

Plastiflex Group NV

SRN

BE-MF-000008049

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW014

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 15 countries total.

Trade name

not provided

UDI-DI code

05404013000982

Basic UDI-DI

54040130000000000000169

Reference / catalog number

HPE15018KT0030GI

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The SEFAM Heated Breathing tube is intended for use with the SEFAM Positive Airway Pressure (PAP) device. The SEFAM Heated breathing tube helps to prevent moisture condensation in the breathing tube of adult patients requiring continuous positive airways pressure or mask ventilation. The SEFAM Heated breathing tube can be used in the sleep lab and in the home. The SEFAM Heated tube is intended for adult patients only. Device under medical supervision.

Additional information URL

https://www.plastiflex.com/

Clinical sizes

• 183 MU10
• 15 MU50

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

• R02010401CPAP CIRCUITS

Certificate health across this manufacturer's portfolio.