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817 device results listed.

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STANDARD™ i Trigger

i-TRG-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722684
Basic UDI-DI: 88001117IPAA06IA01WV
Reference: 16TR10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Wash buffer

i-WBF-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722677
Basic UDI-DI: 88001117IPAA07IA01X8
Reference: 16WB10
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cleanser

i-CLE-01

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722660
Basic UDI-DI: 88001117IPAA04IA01W7
Reference: 16CL10
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i2000

i2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720260
Basic UDI-DI: 88001117IPAA01IA02V8
Reference: 16IA200
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i1000

i1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111720253
Basic UDI-DI: 88001117IPAA01IA01V6
Reference: 16IA100
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

ABOSOL

ABSOL-001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Absology Co., Ltd.
Manufacturer SRN: KR-MF-000026041
UDI-DI: 08800069000001
Basic UDI-DI: 88000690ABSOLHY
Reference: ABSOL-001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

08800047500110

ATPI03

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PCL Inc.
Manufacturer SRN: KR-MF-000029608
UDI-DI: 08800047500110
Basic UDI-DI: 88000475ATPI03GL
Reference: PCLOK II
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900104

SimplexTAS 101 Heating Block

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

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900104
Basic UDI-DI: 880003790010AY
Reference: T0001002
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900005

SimplexTAS 101 Analyzer

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

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900005
Basic UDI-DI: 880003790000AV
Reference: T0001001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

Stool extraction system

NU1800S, NU1801S, NU1802S, NU1803S

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147198954
Basic UDI-DI: 86060147198953Z
Reference: NU1800S
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS System liquid

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147127596
Basic UDI-DI: 86060147183932V
Reference: C1905CL
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS SANITIZING SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147122928
Basic UDI-DI: 86060147183862Y
Reference: C1904CS
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Romania
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS WASH B

IVD Class AIVDR 2017/746On the marketDirect markingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147122850
Basic UDI-DI: 86060147184922Y
Reference: C1902CB
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS WASH A

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147122782
Basic UDI-DI: 860601471837933
Reference: C1901CA
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS

C100Y

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147122614
Basic UDI-DI: 8606014712261YW
Reference: C100Y
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

JUNO Automatic eCLIA 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: 8435287397055
Basic UDI-DI: 843528739705JG
Reference: 7700010
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:59

Manufacturer products View details

Aura POCT CLIA Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287397000
Basic UDI-DI: 843528739700J6
Reference: 7700000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:59

Manufacturer products View details

KROMA Plus iT Automatic Immunological 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: 8435287393309
Basic UDI-DI: 843528739330HT
Reference: 3800070
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

KROMA iT Automatic Immunological 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: 8435287393101
Basic UDI-DI: 843528739310HM
Reference: 3800050
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

Aptiva Instrument System Cuvettes

Instrument System Cuvettes

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126000741
Basic UDI-DI: 84307930458034R
Reference: AC1005
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details