EUDAMED last updated this device on Nov 18, 2025

ELAN 4

40392390000014582R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aesculap AG
UDI-DI code: 04046955153725
Reference / catalog number: GP389SU

ELAN 4 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Aesculap AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Nov 18, 2025

ELAN 4

40392390000014582R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aesculap AG
UDI-DI code: 04046955153725
Reference / catalog number: GP389SU

View device family (Basic UDI)

Device identification

Trade name: ELAN 4
UDI-DI code: 04046955153725
Basic UDI-DI: 40392390000014582R
Reference / catalog number: GP389SU
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ELAN 4 2-RING DISP.REV.TAPER BURR+ D6.0
Additional information URL: https://eifu.bbraun.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04046955153725

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

Z12100980INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES

Critical warnings

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

CW032
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

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

Market distribution

Primary placement in Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 23, 2018	Still on market
Austria	Nov 23, 2018	Still on market
Belgium	Nov 23, 2018	Still on market
Bulgaria	Nov 23, 2018	Still on market
Cyprus	Nov 23, 2018	Still on market
Czechia	Nov 23, 2018	Still on market
Denmark	Nov 23, 2018	Still on market
Estonia	Nov 23, 2018	Still on market
EL	Nov 23, 2018	Still on market
Spain	Nov 23, 2018	Still on market
Finland	Nov 23, 2018	Still on market
France	Nov 23, 2018	Still on market
Croatia	Nov 23, 2018	Still on market
Hungary	Nov 23, 2018	Still on market
Ireland	Nov 23, 2018	Still on market
Italy	Nov 23, 2018	Still on market
Lithuania	Nov 23, 2018	Still on market
Luxembourg	Nov 23, 2018	Still on market
Latvia	Nov 23, 2018	Still on market
Malta	Nov 23, 2018	Still on market
Netherlands	Nov 23, 2018	Still on market
Poland	Nov 23, 2018	Still on market
Portugal	Nov 23, 2018	Still on market
Romania	Nov 23, 2018	Still on market
Sweden	Nov 23, 2018	Still on market
Slovenia	Nov 23, 2018	Still on market
Slovakia	Nov 23, 2018	Still on market

Device identification

Trade name: ELAN 4
UDI-DI code: 04046955153725
Basic UDI-DI: 40392390000014582R
Reference / catalog number: GP389SU
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: ELAN 4 2-RING DISP.REV.TAPER BURR+ D6.0
Additional information URL: https://eifu.bbraun.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Aesculap AG
SRN: DE-MF-000005504
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04046955153725

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

Z12100980INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES

Critical warnings

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

CW032
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

G12 010066 0441Supplemented
Quality management systemNotified body: 0123Expiry: Jun 30, 2026
20334GB450240524Issued
Technical documentationNotified body: 0482Expiry: May 23, 2029
20333GB450240524Issued
Technical documentationNotified body: 0482Expiry: May 23, 2029

Certificates covering this device

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

All products by Aesculap AG

Market distribution

Primary placement in Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 23, 2018	Still on market
Austria	Nov 23, 2018	Still on market
Belgium	Nov 23, 2018	Still on market
Bulgaria	Nov 23, 2018	Still on market
Cyprus	Nov 23, 2018	Still on market
Czechia	Nov 23, 2018	Still on market
Denmark	Nov 23, 2018	Still on market
Estonia	Nov 23, 2018	Still on market
EL	Nov 23, 2018	Still on market
Spain	Nov 23, 2018	Still on market
Finland	Nov 23, 2018	Still on market
France	Nov 23, 2018	Still on market
Croatia	Nov 23, 2018	Still on market
Hungary	Nov 23, 2018	Still on market
Ireland	Nov 23, 2018	Still on market
Italy	Nov 23, 2018	Still on market
Lithuania	Nov 23, 2018	Still on market
Luxembourg	Nov 23, 2018	Still on market
Latvia	Nov 23, 2018	Still on market
Malta	Nov 23, 2018	Still on market
Netherlands	Nov 23, 2018	Still on market
Poland	Nov 23, 2018	Still on market
Portugal	Nov 23, 2018	Still on market
Romania	Nov 23, 2018	Still on market
Sweden	Nov 23, 2018	Still on market
Slovenia	Nov 23, 2018	Still on market
Slovakia	Nov 23, 2018	Still on market

ELAN 4

ELAN 4

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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