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291 device results listed.

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Lateral Flow (LF) Portable Reader

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842840
Basic UDI-DI: 0810047980015AGN
Reference: ACA101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dry-type Fluorescent Immunoassay Analyzer

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983798
Basic UDI-DI: 0810047980004BGG
Reference: AFR-ACO600
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

LF Reader Plus

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983347
Basic UDI-DI: 0810047980000BG4
Reference: ATR-ACO300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047980414
Basic UDI-DI: 0810047980004AGE
Reference: AFR-ACO200
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

LDX

Cholestech LDX™ Analyzer

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

Manufacturer: Alere San Diego, Inc.
Manufacturer SRN: US-MF-000008348
UDI-DI: 00810039380529
Basic UDI-DI: 081003938LDX0009YG
Reference: 14-875
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Ireland
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 16.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Elisa Microplate Reader

BK-EL series

IVD Class AIVDR 2017/746On the market

Manufacturer: Biobase Biogrand Co., Ltd.
Manufacturer SRN: CN-MF-000030480
UDI-DI: 06978527670003
Basic UDI-DI: 06978527BK-EL****NP
Reference: BK-EL10A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer iSort 300 Dry fluorescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546543397
Basic UDI-DI: 0697454654M0300YN
Reference: M0300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer iRaTe 300 Dry fluorescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541232
Basic UDI-DI: 0697454654L0300YB
Reference: L0300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

N Cuvette Segments for BN ProSpec

IVDR_27_MAR EB_A_BN_PS_Cuv

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012334
Basic UDI-DI: 0405686902111UT
Reference: 10446539
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

N Evaporation Caps for Control Vials (2.5 mL)

IVDR_27_MAR EB_A_N_Eva_Caps

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012297
Basic UDI-DI: 0405686902112UV
Reference: 10446534
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

N Predilution Wells

IVDR_27_MAR EB_A_N_Predil_Well

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012174
Basic UDI-DI: 0405686902110UR
Reference: 10446521
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:37

Manufacturer products View details

Atellica NEPH 630 System

IVDR_27_MAR EB_A_INST_ANEPH630

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414006239
Basic UDI-DI: 0405686900854W2
Reference: 11239861
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:12

Manufacturer products View details

BN II System

IVDR_27_MAR EB_A_INST_BNII

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414002903
Basic UDI-DI: 0405686900856W6
Reference: 11254820
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:12

Manufacturer products View details

BD PhoenixSpec

BD PhoenixSpec™ Nephelometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904409104
Basic UDI-DI: 038290JFFJQZFU8P
Reference: 440910
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

111938738460

Ledetect96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: biomed Dr. Wieser GmbH
Manufacturer SRN: AT-MF-000028269
UDI-DI: 111938738460
Basic UDI-DI: PP13707READER74
Reference: Many
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:43

Manufacturer products View details

iNSTA XPLOR® P

iNSTA XPLOR P

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: STRUmed Solutions Private Limited
Manufacturer SRN: IN-MF-000023119
UDI-DI: D-iNSTAXPLORPF8
Basic UDI-DI: B-iNSTAXPLORPF8
Reference: iNSTA XPLOR® P PA 001
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Greece
Authorised representative: Amstermed B.V.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Test Reader

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

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: 06978274250411
Basic UDI-DI: 6978274250000DG
Reference: aca-A02
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Dry-type Fluorescent Immunoassay Analyzer

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983880
Basic UDI-DI: 0810047980004BGG
Reference: AFR-ACO600
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

N Evaporation Caps for Reagent Vials (5 ml)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012303
Basic UDI-DI: 0405686902112UV
Reference: 10446535
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:13

Manufacturer products View details

Lateral Flow (LF) Portable Reader

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842857
Basic UDI-DI: 0810047980015AGN
Reference: ACA101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details