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315 device results listed.

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The Lab 004 (DB-3910)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486028659
Basic UDI-DI: 4987486BC0105581GU
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460104
Basic UDI-DI: 489714646MR003JE
Reference: HTSH-2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

BIOLIS 30i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262016002
Basic UDI-DI: 458026201BIOLIS30i2W
Reference: 60-01-0001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

AXINON® System

AXINON System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: numares AG
Manufacturer SRN: DE-MF-000022282
UDI-DI: 04260539610217
Basic UDI-DI: 426053961AX0700X5
Reference: AX0700
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

Selectra Mach5

6004-301

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860549
Basic UDI-DI: 37017008Mach-seriesPP
Reference: 6004-301
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Pentra C200 Standard

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006689
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090005
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

CA-310

Clinical Chemistry Analyzer CA-310 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906918
Basic UDI-DI: 0456016CA-310-NOISE9D
Reference: CA000002750
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
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-400

Clinical Chemistry Analyzer CA-400 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906857
Basic UDI-DI: 0456016CA-400-NOISE9H
Reference: CA000001475
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
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-270

Clinical Chemistry Analyzer CA-270 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906833
Basic UDI-DI: 0456016CA-270-NOISEC8
Reference: CA000001474
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Iceland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

HumaLyzer 4000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145192305
Basic UDI-DI: 04033145CC18250DZ
Reference: 18250
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 18:27

Manufacturer products View details

HumaLyzer Primus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145118664
Basic UDI-DI: 04033145CC18200DJ
Reference: 18200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

HumaStar 300SR

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145086802
Basic UDI-DI: 04033145CC16930EG
Reference: 16930
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

ITALO M

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 8053617720016ZF
Basic UDI-DI: B-8053617720016ZF
Reference: CCIM
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 00:58

Manufacturer products View details

VCHEMY S® EVO

EVO-A01

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

Manufacturer: Chengdu Seamaty Technology Co.,Ltd
Manufacturer SRN: CN-MF-000033937
UDI-DI: 06973947590092
Basic UDI-DI: 6973947590092HC
Reference: EVO-A01
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

MC-200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600336
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600343
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

SPIN XL

Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673019235
Basic UDI-DI: 8431673INTF02WM
Reference: 5004100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:12

Manufacturer products View details

06979845480114

ACA820

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Hunan Runmei Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000017635
UDI-DI: 06979845480114
Basic UDI-DI: 697984548ACA820PC
Reference: RM-R03-013-1.0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:27

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: 06971674860006
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

08033622964988

BT 3700

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964988
Basic UDI-DI: 0803362296498UX
Reference: BT 3700I
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details