Organization name

Acandis GmbH

SRN

DE-MF-000006259

Manufacturer status

Active

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

• Do not re-use
• Do not use if package is damaged
• Do not use past indicated date
• Do not resterilize
• Consult instructions for use

Primary placement in Germany; available across 32 countries total.

Trade name

NeuroBridge

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.

04260650331855

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.

426065033NeuroBridge3L

Reference / catalog number

01-000510

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 25 MU105
• 0.039 MU28
• 145 MU10

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

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

• C010499ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.