Organization name

Cochlear Bone Anchored Solutions AB

SRN

SE-MF-000012413

Manufacturer status

Active

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

• Consult instructions for use
• Caution

Primary placement in Sweden; available across 32 countries total.

Trade name

Cochlear® Baha® SoundArc™ Extra Large

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.

09321502040891

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.

9321502BSoundArcV3

Reference / catalog number

P807178

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.cochlear.com/manuals

Clinical sizes

• Extra Large

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

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

• Y214599HEARING AIDS - OTHER

• Class I medical devices in EUDAMED

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