Organization name

Breas Medical AB

SRN

SE-MF-000001061

Manufacturer status

Active

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

• CW010

  Read user instructions before use.
• CW007

  Do not use if seal on the packaging is broken
• CW262

  Single patient use
• CW999

  Maximum use 7 days.

Primary placement in Sweden; available across 15 countries total.

Trade name

Clearo IPPB Circuit

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.

07321820082773

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.

7321820109998U

Reference / catalog number

008277

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

9

Additional product description

—

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.

• R020106IPPB CIRCUITS

• Class IIa medical devices in EUDAMED

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