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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

Aptiva® Multi-Analyte Instrument

AP5000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426951307227
Basic UDI-DI: 84269513072276Z
Reference: AP5000
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 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 IFA

VS3002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865131
Basic UDI-DI: 84269508651319P
Reference: VS3002
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 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA + Incubator

VS3000i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865100
Basic UDI-DI: 84269508651009C
Reference: VS3000i
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 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA-Lyser® 3000 ELISA/IFA

VS3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950865094
Basic UDI-DI: 8426950865094AA
Reference: VS3000
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 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA View® AUTOLoader

ADLR1000

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950643708
Basic UDI-DI: 84269506437088U
Reference: ADLR1000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA View® Automated Fluorescence Microscope

NV2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950621614
Basic UDI-DI: 84269506216147E
Reference: NV2000
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-FLASH Cuvettes

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950554448
Basic UDI-DI: 84269506397259T
Reference: 3000-8206
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:10

Manufacturer products View details

BLOT MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660513
Basic UDI-DI: 805961666BLOTMODULETU
Reference: OR-0600
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 12:36

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PLATE-WASHER UP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660506
Basic UDI-DI: 805961666PLATEWASHERUP74
Reference: OR-0100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

PLATE READER

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660292
Basic UDI-DI: 805961666PLATEREADERLZ
Reference: OR-9710220
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP22 IF BLOT ELITE

AP ELISA-IFA-BLOT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660179
Basic UDI-DI: 805961666APELISAIFABLOTMA
Reference: OR-102403
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP22 IF ELITE

AP ELISA-IFA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660148
Basic UDI-DI: 805961666APELISAIFAG2
Reference: OR-102402
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Portugal
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP22 ELITE

AP ELISA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660131
Basic UDI-DI: 805961666APELISATZ
Reference: OR-102401
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP-BLOT ELITE

AP BLOT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660124
Basic UDI-DI: 805961666APBLOTLA
Reference: OR-1013112
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP16 IF BLOT ELITE

AP IFA-BLOT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660049
Basic UDI-DI: 805961666APIFABLOTLE
Reference: OR-1166011
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

AP16 IF ELITE

AP IFA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660032
Basic UDI-DI: 805961666APIFAG9
Reference: OR-101600
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

08059304340239

dIFine ANCA Classifier

IVD Class BIVDR 2017/746On the market

Manufacturer: Visia Lab S.r.l.
Manufacturer SRN: IT-MF-000013016
UDI-DI: 08059304340239
Basic UDI-DI: 805930434dIFineANCAPV
Reference: FA08ANCA
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:22

Manufacturer products View details

08059304340222

dIFine DNA Classifier

IVD Class BIVDR 2017/746On the market

Manufacturer: Visia Lab S.r.l.
Manufacturer SRN: IT-MF-000013016
UDI-DI: 08059304340222
Basic UDI-DI: 805930434dIFineDNAMX
Reference: FA08DNA
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:22

Manufacturer products View details

08059304340215

dIFine ANA HEp-2 Classifier

IVD Class BIVDR 2017/746On the market

Manufacturer: Visia Lab S.r.l.
Manufacturer SRN: IT-MF-000013016
UDI-DI: 08059304340215
Basic UDI-DI: 805930434dIFineANAMG
Reference: FA08ANA
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 03.07.2026 12:22

Manufacturer products View details