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89 device results listed.

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Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302698
Basic UDI-DI: 6936895BS00326
Reference: BK-410
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300298
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
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

CS-600B

CS-600B CS-650 CS-680 CS-1200

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504647
Basic UDI-DI: 69257945W0201010102D0JL
Reference: 3000085
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Biochemical Analyzer MBM001

MBM001

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611463
Basic UDI-DI: 692180764008FK
Reference: JY42MBM001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus

IVD Class AIVDR 2017/746On the market

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468416
Basic UDI-DI: 5745000468EU02000500019R
Reference: EU0200050001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

Pentra C400 Standard

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006542
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241012
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

SENTiFIT 800

SENTiFIT ®800 Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906895
Basic UDI-DI: 0456016SENTiFIT9D
Reference: 550800
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA-800

Clinical Chemistry Analyzer CA-800 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906871
Basic UDI-DI: 0456016CA-800-NOISECD
Reference: CA000001551
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

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06973316740325

Speedry Chem

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740325
Basic UDI-DI: 697331674DBA00029S
Reference: 68000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer ACCENT-400

ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601691
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:21

Manufacturer products View details

08033622965046

AUTOLYSER 450

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622965046
Basic UDI-DI: 0803362296504TZ
Reference: AUTOLYSER 450
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

AUTOLYSER 450

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964902
Basic UDI-DI: 0803362296490UF
Reference: ATLS450 S/I-C
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

AS660 S/I

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964797
Basic UDI-DI: 0803362296479UT
Reference: AS660 S/I
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

08033622964582

BT 4500V

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964582
Basic UDI-DI: 0803362296483UJ
Reference: BT 4500V-A-A
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 4500S S/ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964445
Basic UDI-DI: 0803362296444U8
Reference: BT 4500S S/I
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

LordsMed Fully Auto Biochemistry Analyzer (400 TPH)

LM004

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470044
Basic UDI-DI: 890619447LM004F5
Reference: LM004
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

LIDA 800 Automatic Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393804
Basic UDI-DI: 843528739380JA
Reference: 1805800
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

LIDA 300 Automatic Clinical Chemistry Analyzer

LIDA-300 Automatic Clinical Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393606
Basic UDI-DI: 843528739360J4
Reference: 1805000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

LIDA 500 Automatic Clinical Chemistry Analyzer

LIDA-500 Automatic Clinical Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393408
Basic UDI-DI: 843528739340HW
Reference: 1805500
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

08435287101317

[AUTOANALYZER] BA400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287101317
Basic UDI-DI: 8435287191BA40000000J5
Reference: 83400
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details