EUDAMED last updated this device on Jun 29, 2026

Xpert®

B-07332940001834

On the marketIVDD — General

Applicable legislation: —
Organization name: Cepheid
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 07332940001834
Reference / catalog number: GXBCRABL-10

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Xpert® is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Cepheid. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Xpert®
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 07332940001834
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. View in glossary →: B-07332940001834
Reference / catalog number: GXBCRABL-10
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Xpert® BCR-ABL Ultra
Additional information URL: No additional information URL provided by the manufacturer.
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)07332940001834

EMDN nomenclature code(s)

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

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Critical warnings

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

Consult instructions for use
Biological risks
In IFU
P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.
If skin irritation occurs: Get medical advice/attention
P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do continue rinsing
P332 – If skin irritation occurs: P313 – Get medical advice/attention.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Netherlands; available across 17 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Apr 17, 2020	Still on market
Austria	Jun 24, 2020	Still on market
Belgium	May 11, 2020	Still on market
Czechia	Jun 18, 2021	Still on market
Germany	Jan 17, 2020	Still on market
EL	Oct 28, 2020	Still on market
Spain	Jan 8, 2020	Still on market
Finland	Aug 3, 2020	Still on market
France	Feb 28, 2020	Still on market
Italy	Feb 7, 2020	Still on market
Lithuania	Oct 17, 2024	Still on market
Latvia	Jul 1, 2020	Still on market
Norway	Feb 22, 2023	Still on market
Poland	Aug 6, 2020	Still on market
Portugal	Apr 8, 2021	Still on market
Sweden	Oct 2, 2020	Still on market
Türkiye	Jan 13, 2022	Still on market

Related searches

IVDD — General medical devices in EUDAMED

Device identification

Trade name: Xpert®
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 07332940001834
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. View in glossary →: B-07332940001834
Reference / catalog number: GXBCRABL-10
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Critical warnings

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

Consult instructions for use
Biological risks
In IFU
P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.
If skin irritation occurs: Get medical advice/attention
P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do continue rinsing
P332 – If skin irritation occurs: P313 – Get medical advice/attention.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Netherlands; available across 17 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Apr 17, 2020	Still on market
Austria	Jun 24, 2020	Still on market
Belgium	May 11, 2020	Still on market
Czechia	Jun 18, 2021	Still on market
Germany	Jan 17, 2020	Still on market
EL	Oct 28, 2020	Still on market
Spain	Jan 8, 2020	Still on market
Finland	Aug 3, 2020	Still on market
France	Feb 28, 2020	Still on market
Italy	Feb 7, 2020	Still on market
Lithuania	Oct 17, 2024	Still on market
Latvia	Jul 1, 2020	Still on market
Norway	Feb 22, 2023	Still on market
Poland	Aug 6, 2020	Still on market
Portugal	Apr 8, 2021	Still on market
Sweden	Oct 2, 2020	Still on market
Türkiye	Jan 13, 2022	Still on market

Xpert®

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Related devices

Certificates covering this device

Certificates