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315 device results listed.

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CLIMA JR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RAL TECNICA PARA EL LABORATORIO, S.A.
Manufacturer SRN: ES-MF-000000306
UDI-DI: 08435491999854
Basic UDI-DI: 84354919CLIMAJR01L3
Reference: RA135000
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: 03.07.2026 14:07

Manufacturer products View details

KROMA Plus Automatic Clinical Chemistry Analyzer

KROMA PLUS Automatic Clinical Chemistry 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: 8435287393200
Basic UDI-DI: 843528739320HQ
Reference: 1800100
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: 03.07.2026 13:58

Manufacturer products View details

KROMA Automatic Clinical Chemistry 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: 8435287393002
Basic UDI-DI: 843528739300HJ
Reference: 1800050
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: 03.07.2026 13:58

Manufacturer products View details

08435287109986

[RANDOM ACCESS ANALYZER] A15

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287109986
Basic UDI-DI: 8435287191A15000000072
Reference: 83105C
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: 03.07.2026 13:46

Manufacturer products View details

08435287108446

[AUTOANALYZER] BA200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108446
Basic UDI-DI: 8435287191BA20000000GX
Reference: 83200
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: 03.07.2026 13:46

Manufacturer products View details

08435287108101

[RANDOM ACCESS ANALYZER] A25

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108101
Basic UDI-DI: 8435287191A2500000007R
Reference: 83101
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: 03.07.2026 13:46

Manufacturer products View details

ILab Aries w/o ISE

000160258302

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426950490999
Basic UDI-DI: 8426950490999AB
Reference: 000160258302
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: 03.07.2026 13:05

Manufacturer products View details

Clini5

IVD Class ANot specifiedOn the market

Manufacturer: Callegari S.r.l.
Manufacturer SRN: IT-MF-000035568
UDI-DI: 08057502880014
Basic UDI-DI: 805750288000139
Reference: 126181P
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: 03.07.2026 11:34

Manufacturer products View details

Pulsar

Pulsar - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401262
Basic UDI-DI: 805360894ES0000553
Reference: ES00005-A
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: 03.07.2026 09:56

Manufacturer products View details

Alcor

Alcor - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401194
Basic UDI-DI: 805360894ES000024V
Reference: ES00002-B
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: 03.07.2026 09:56

Manufacturer products View details

Duo

Duo - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089400968
Basic UDI-DI: 805360894ES000034X
Reference: ES00003-A
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: 03.07.2026 09:56

Manufacturer products View details

Core

Core - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401026
Basic UDI-DI: 805360894ES000044Z
Reference: ES00004-A
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: 03.07.2026 09:56

Manufacturer products View details

Vchemys

VCS-00P

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

Manufacturer: Voden Medical Instruments S.p.A.
Manufacturer SRN: IT-MF-000029236
UDI-DI: 08033717689994
Basic UDI-DI: 803371768VCHEMYSUK
Reference: VCS-00P
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: 03.07.2026 08:11

Manufacturer products View details

KENZA MAX PLUS BioChemisTry PHOTOMETER

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BPC Biosed Srl
Manufacturer SRN: IT-MF-000032961
UDI-DI: 08033675433493
Basic UDI-DI: 803367543KM+J7
Reference: KENZA MAX +
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: 03.07.2026 08:09

Manufacturer products View details

Automated Biochemistry Analyzer GLOBAL 240

Automated Biochemistry Analyzer < 400 tests/h

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BPC Biosed Srl
Manufacturer SRN: IT-MF-000032961
UDI-DI: 08033675432809
Basic UDI-DI: 803367543GLOB2AF
Reference: 19-0000
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: 03.07.2026 08:09

Manufacturer products View details

CM 160

M-2300

IVD Class AIVDR 2017/746No longer on the marketInstrument

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778043285
Basic UDI-DI: 7791778W02010101011061ZA
Reference: 9351061
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1080

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020372
Basic UDI-DI: 6978848020372HJ
Reference: A00814000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020266
Basic UDI-DI: 6978848020266HJ
Reference: A00813000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020044
Basic UDI-DI: 6978848020044GW
Reference: A00812000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

SMT-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020020
Basic UDI-DI: 6978848020020GG
Reference: A00815000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details