EUDAMED last updated this device on Sep 17, 2025

B.Braun

40392390000005292G

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: B. Braun Avitum AG
UDI-DI code: 04046964447341
Reference / catalog number: 7104324

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Sep 17, 2025

B.Braun

40392390000005292G

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: B. Braun Avitum AG
UDI-DI code: 04046964447341
Reference / catalog number: 7104324

View device family (Basic UDI)

Device identification

Trade name: B.Braun
UDI-DI code: 04046964447341
Basic UDI-DI: 40392390000005292G
Reference / catalog number: 7104324
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: bioLogic Fusion
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)04046964447341

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.

Z12090201HAEMODIALYSIS EQUIPMENT

Critical warnings

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

CW027
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	Dec 1, 2016	Still on market
Austria	Dec 1, 2016	Still on market
Belgium	Dec 1, 2016	Still on market
Bulgaria	Dec 1, 2016	Still on market
Cyprus	Dec 1, 2016	Still on market
Czechia	Dec 1, 2016	Still on market
Denmark	Dec 1, 2016	Still on market
Estonia	Dec 1, 2016	Still on market
EL	Dec 1, 2016	Still on market
Spain	Dec 1, 2016	Still on market
Finland	Dec 1, 2016	Still on market
France	Dec 1, 2016	Still on market
Croatia	Dec 1, 2016	Still on market
Hungary	Dec 1, 2016	Still on market
Ireland	Dec 1, 2016	Still on market
Italy	Dec 1, 2016	Still on market
Lithuania	Dec 1, 2016	Still on market
Luxembourg	Dec 1, 2016	Still on market
Latvia	Dec 1, 2016	Still on market
Malta	Dec 1, 2016	Still on market
Netherlands	Dec 1, 2016	Still on market
Poland	Dec 1, 2016	Still on market
Portugal	Dec 1, 2016	Still on market
Romania	Dec 1, 2016	Still on market
Sweden	Dec 1, 2016	Still on market
Slovenia	Dec 1, 2016	Still on market
Slovakia	Dec 1, 2016	Still on market

Device identification

Trade name: B.Braun
UDI-DI code: 04046964447341
Basic UDI-DI: 40392390000005292G
Reference / catalog number: 7104324
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: bioLogic Fusion
Additional information URL: https://eifu.bbraun.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: B. Braun Avitum AG
SRN: DE-MF-000005127
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04046964447341

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.

Z12090201HAEMODIALYSIS EQUIPMENT

Critical warnings

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

CW027
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.

G15 066097 0125Issued
Quality management systemNotified body: 0123Expiry: Oct 1, 2030

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	Dec 1, 2016	Still on market
Austria	Dec 1, 2016	Still on market
Belgium	Dec 1, 2016	Still on market
Bulgaria	Dec 1, 2016	Still on market
Cyprus	Dec 1, 2016	Still on market
Czechia	Dec 1, 2016	Still on market
Denmark	Dec 1, 2016	Still on market
Estonia	Dec 1, 2016	Still on market
EL	Dec 1, 2016	Still on market
Spain	Dec 1, 2016	Still on market
Finland	Dec 1, 2016	Still on market
France	Dec 1, 2016	Still on market
Croatia	Dec 1, 2016	Still on market
Hungary	Dec 1, 2016	Still on market
Ireland	Dec 1, 2016	Still on market
Italy	Dec 1, 2016	Still on market
Lithuania	Dec 1, 2016	Still on market
Luxembourg	Dec 1, 2016	Still on market
Latvia	Dec 1, 2016	Still on market
Malta	Dec 1, 2016	Still on market
Netherlands	Dec 1, 2016	Still on market
Poland	Dec 1, 2016	Still on market
Portugal	Dec 1, 2016	Still on market
Romania	Dec 1, 2016	Still on market
Sweden	Dec 1, 2016	Still on market
Slovenia	Dec 1, 2016	Still on market
Slovakia	Dec 1, 2016	Still on market

B.Braun

B.Braun

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

Related devices