Organization name

Brainlab SE

SRN

DE-MF-000006183

Manufacturer status

Active

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

• Consult instructions for use
• Single patient multiple use
• MR SAFE

Primary placement in Germany; available across 32 countries total.

Trade name

Cranial 4Pi Stereotactic Mask 3.2 mm (1 pc)

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.

04056481146986

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.

4056481Cranial4PiMasksEA

Reference / catalog number

43454-01A

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://userguides.brainlab.com/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 04056481146986× 1 unitBase unit
  • 04056481146979× 5 units

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

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

• Z11019080VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.