Organization name

Breas Medical AB

SRN

SE-MF-000001061

Manufacturer status

Active

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

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

• Caution

  Use only with continuous airflow. Do not block the leak port or anti-asphyxia valve. Patients unable to remove the mask must use it only under qualified supervision and clinician advice. Stop use if adverse reactions occur.

Primary placement in Sweden; available across 20 countries total.

Trade name

Apto® F01 Full Face Mask Medium

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.

07321820099733

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.

73218202099997

Reference / catalog number

009973

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Medium

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

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

• R0301010201CPAP MASKS
• R0301010202NIV MASKS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.