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817 device results listed.

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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® 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

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

AL1200 analyzer 120

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320951032
Basic UDI-DI: 805432095AL1200ANALYZER72
Reference: AL800001
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 10:04

Manufacturer products View details

Pulsar 350

Pulsar 350 - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089444764
Basic UDI-DI: 805360894ES0000859
Reference: ES00008
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details

NeaT LX Latex Removal Solution 3 x 27 mL

NeaT LX Latex Removal Solution

IVD Class AIVDR 2017/746On the marketDirect markingKit

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089442234
Basic UDI-DI: 805360894KIT08009NU
Reference: KIT08009E-081B
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details

NeaT C Cleaning solution 2 x 250 mL

NeaT C Cleaning solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401330
Basic UDI-DI: 805360894KIT08006NN
Reference: KIT08006E-500B
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details