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295 device results listed.

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Smart Care

Fluorescent Immunoassay Analyzer

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018290315
Basic UDI-DI: 622301829FIAM64
Reference: SC101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200185
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0001-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200208
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0005-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

05056393500004

SoToxa Oral Fluid Mobile Test System

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393500004
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400P
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Ireland
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 23.09.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

08809446480306

Q-Smart

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480306
Basic UDI-DI: 880944648QSM29RD
Reference: MQSM2901
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Smart Care

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018290346
Basic UDI-DI: 622301829FIAM64
Reference: SC5000
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Smart Care

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018290339
Basic UDI-DI: 622301829FIAM64
Reference: SC301
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

Smart Care

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018290322
Basic UDI-DI: 622301829FIAM64
Reference: SC201
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501353

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501353
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SUS
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501339

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501339
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SEU
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501346

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501346
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SUK
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501063

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501063
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500SUK
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393500752

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393500752
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500016
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501025

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501025
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500SAUS
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501087

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501087
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500SUS
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501049

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501049
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500SEU
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393500622

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393500622
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX500P
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501322

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501322
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SAUS
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501421

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501421
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400016
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® SARS-2 control samples

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1204SCQQ
Basic UDI-DI: B-1204SCQQ
Reference: 1204SC
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:37

Manufacturer products View details