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62 device results listed.

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BACT/LINK® software kit

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026120016
Basic UDI-DI: B-03573026120016
Reference: 212897
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

06941967235996

EXB 120, EXB 120S, EXB 120P, EXB60-Lite, EXB60-Vita, EXB60-Nova

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967235996
Basic UDI-DI: 69732628600112ZJ
Reference: 0501101
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

06941967236009

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236009
Basic UDI-DI: 69732628600112ZJ
Reference: 0501102
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967236016

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236016
Basic UDI-DI: 69732628600112ZJ
Reference: 0501103
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243953

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243953
Basic UDI-DI: 69732628600112ZJ
Reference: 0502402
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243977

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243977
Basic UDI-DI: 69732628600112ZJ
Reference: 0502406
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243960

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243960
Basic UDI-DI: 69732628600112ZJ
Reference: 0502404
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Blood Culture System

FA-M400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115933
Basic UDI-DI: 69449040AB41000072Q
Reference: FA-M400
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Blood Culture System

FA-N60、FA-N120、FA-N240

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053070430
Basic UDI-DI: 69449040AB41000032G
Reference: FA-N120
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06938010900291

TDR-X060\TDR-X120\TDR-X120II\TDR-X240\TDR-X360

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Hunan Mindray Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022479
UDI-DI: 06938010900291
Basic UDI-DI: 69380109002914T
Reference: TDR-X060\TDR-X120\TDR-X120II\TDR-X240\TDR-X360
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:05

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Blood Culture System

BK-BC series

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302902
Basic UDI-DI: 69368953029BC***5M
Reference: BK-BC32
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Blood Culture System

ABC-40,ABC-60,ABC-120,ABC-240,ABC-480

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsDirect markingInstrumentProfessional testing

Manufacturer: RECOVERY (HK) TECHNOLOGY LIMITED
Manufacturer SRN: HK-MF-000048304
UDI-DI: 04897147600011
Basic UDI-DI: 489714760RECOVERY0001MV
Reference: ABC-40,ABC-60,ABC-120,ABC-240,ABC-480
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

04897138850050

SepCheck

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grant Technology (HK) Co., Ltd.
Manufacturer SRN: HK-MF-000041730
UDI-DI: 04897138850050
Basic UDI-DI: 489713885SepCheckV2
Reference: 100.00kg
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 31.07.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® 3D RIGHT INCUBATION MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026049591
Basic UDI-DI: 357302BUDI000895UP
Reference: 210161
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® 3D LEFT INCUBATION MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026049577
Basic UDI-DI: 357302BUDI000141SV
Reference: 210159
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® 3D CONTROL MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026049522
Basic UDI-DI: 357302BUDI000140ST
Reference: 210147
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® 3D LEFT COMBINATION MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026047573
Basic UDI-DI: 357302BUDI000918UA
Reference: 200291
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® 3D RIGHT COMBINATION MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026047566
Basic UDI-DI: 357302BUDI000886UN
Reference: 200290
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 22.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® VIRTUO®

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026369774
Basic UDI-DI: 357302BUDI000511T8
Reference: 411661
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

BACT/ALERT® VIRTUO®

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux, Inc.
Manufacturer SRN: US-MF-000011802
UDI-DI: 03573026369767
Basic UDI-DI: 357302BUDI000147T9
Reference: 411660
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details