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311 device results listed.

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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

BT 3700

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964964
Basic UDI-DI: 0803362296496UT
Reference: BT 3700
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

BT 1600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964926
Basic UDI-DI: 0803362296492UK
Reference: BT 1600
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 03:29

Manufacturer products View details

08033622964865

AUTOLYSER ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964865
Basic UDI-DI: 0803362296486UQ
Reference: AUTOLYSER ISE
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 3600 S/I

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964766
Basic UDI-DI: 0803362296476UM
Reference: BT 3600 S/I
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 03:29

Manufacturer products View details

BT 3600

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964759
Basic UDI-DI: 0803362296475UK
Reference: BT 3600
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details