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237 device results listed.

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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

Bolt (CLIA)

00500-CL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B35000500CL0
Basic UDI-DI: ++B35000500CLJP
Reference: 00500-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Bolt

00500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350005000
Basic UDI-DI: ++B35000500BA
Reference: 00500
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

HAILSTORM

00350

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350003500
Basic UDI-DI: ++B35000350BF
Reference: 00350
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

ThunderBolt EIA (CLIA)

00300-CL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B35000300CL0
Basic UDI-DI: ++B35000300CLHZ
Reference: 00300-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

ThunderBolt EIA

00300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350003000
Basic UDI-DI: ++B35000300AY
Reference: 00300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-ImmuView_Reader_1SE

ImmuView Reader version 1.0

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: D-ImmuView_Reader_1SE
Basic UDI-DI: B-ImmuView_Reader_1SE
Reference: 18344
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 14.07.2026 02:16

Manufacturer products View details

Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186848514
Basic UDI-DI: 0810047980010AG7
Reference: ACA001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

QMIA

QMAR04

IVD generalIVDDNo longer on the marketInstrumentProfessional testing

Manufacturer: QuantaMatrix Inc.
Manufacturer SRN: KR-MF-000022784
UDI-DI: 08800044300164
Basic UDI-DI: B-08800044300164
Reference: QMAR04
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 10.07.2026 01:26

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: 00810047989042
Basic UDI-DI: 0810047980010AG7
Reference: ACA202
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 09.07.2026 22:58

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: 00810047988526
Basic UDI-DI: 0810047980010AG7
Reference: ACA202
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 09.07.2026 22:58

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: 00810047989059
Basic UDI-DI: 0810047980010AG7
Reference: ACA203
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 09.07.2026 22:58

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: 00810186843311
Basic UDI-DI: 0810047980010AG7
Reference: ACA204
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 09.07.2026 22:58

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: 00810186846428
Basic UDI-DI: 0810047980010AG7
Reference: ACA204
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 09.07.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed CLIA Reader

LM007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470068
Basic UDI-DI: 890619447LM007FB
Reference: LM007
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

Q-STATION ELITE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480276
Basic UDI-DI: 880944648QST09SA
Reference: MQST0901
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

08809408861624

S-Blot 3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408861624
Basic UDI-DI: 88094088SBF-001NQ
Reference: SBFD001E
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

FREND System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540207
Basic UDI-DI: 880931754FRENDKQ
Reference: F10
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ABOSOL

ABSOL-001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Absology Co., Ltd.
Manufacturer SRN: KR-MF-000026041
UDI-DI: 08800069000001
Basic UDI-DI: 88000690ABSOLHY
Reference: ABSOL-001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

08800047500110

ATPI03

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PCL Inc.
Manufacturer SRN: KR-MF-000029608
UDI-DI: 08800047500110
Basic UDI-DI: 88000475ATPI03GL
Reference: PCLOK II
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details