Organization name

Advanced Bionics LLC

SRN

US-MF-000019344

Manufacturer status

Active

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

• Do not re-use
• MR UNSAFE

Primary placement in Germany; available across 26 countries total.

Trade name

HiFocus™ MS Electrode Insertion Tool Kit

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.

00840094417366

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.

08400944CI4507Y3

Reference / catalog number

CI-4507

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

HiFocus™ Mid-Scala Electrode Insertion Tool Kit

Additional information URL

https://www.advancedbionics.com/ifu

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.

• J0380AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• G70 077725 0026Supplemented
  Technical documentationNotified body: TÜV SÜD Product Service GmbH (0123)Expiry: Sep 21, 2027