Organization name

Aesculap AG

SRN

DE-MF-000005504

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Do not use past indicated date

Primary placement in Germany; available across 27 countries total.

Trade name

ELAN 4

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.

04046964559310

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.

40392390000014572P

Reference / catalog number

GP163R

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

1

Additional product description

ELAN 4 1-RING DIAMOND BURR COARSE D2.3

Additional information URL

https://eifu.bbraun.com/

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.

• Z12100980INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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