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IN008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020013
Basic UDI-DI: 081687002IN00823
Reference: IN008
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

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IN010

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020006
Basic UDI-DI: 081687002IN010ZK
Reference: IN010
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

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Automatic chemiluminescence Immunoassay Analyzer

Automatic chemiluminescence Immunoassay Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510341
Basic UDI-DI: 0810164510010N4
Reference: EQA01-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:57

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Rapid Cup Test Reader

Rapid Cup Test Reader

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510327
Basic UDI-DI: 0810164510009NK
Reference: EQB01-RD
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

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Rapid Test Reader

Rapid Test Reader

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510310
Basic UDI-DI: 0810164510007NF
Reference: EQA01-RD
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

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Fluorescence Immunoasasy Analyzer

Fluorescence Immunoasasy Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510273
Basic UDI-DI: 0810164510000MZ
Reference: EQA01-FI
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Belgium
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

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Lateral Flow (LF) Portable Reader

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

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Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou

Fluorescence Immunoassay Analyzer

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047985235
Basic UDI-DI: 0810047980010AG7
Reference: ACA001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

Dry-type Fluorescent Immunoassay Analyzer

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

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Automatic Chemiluminescence Immunoassay Analyzer,Brand:Asterlith

Automatic Chemiluminescence Immunoassay Analyzer,Brand:Asterlith

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983361
Basic UDI-DI: 0810047980003AGB
Reference: ACIR-ACO100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

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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

LF Reader

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983309
Basic UDI-DI: 0810047980000AG2
Reference: ATR-001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

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

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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

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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

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 iMAGIN 1800 Chemiluminescence Immunoassay Analyzer

iMAGIN 1800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541256
Basic UDI-DI: 0697454654C1800W8
Reference: C1800
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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

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

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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

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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

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