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EMAG®

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026471859
Basic UDI-DI: 357302BUDI000544TP
Reference: 418591
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

myCROBE® Fully Automated Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696306526
Basic UDI-DI: 859569630080QR
Reference: MC100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

croBEE® 2.0 Nucleic Acid Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302955
Basic UDI-DI: 859569630053QN
Reference: CB2NA100
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

croBEE Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302450
Basic UDI-DI: 859569630047QT
Reference: CBRT5/96
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

myCROBE® Fully Automated Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300050
Basic UDI-DI: 859569630052QL
Reference: MC100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

croBEE Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302467
Basic UDI-DI: 859569630047QT
Reference: CBRT4/96
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

D-697603130MHGS01AKZ9U

MHGS01A

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130MHGS01AKZ9U
Basic UDI-DI: B-697603130MHGS01AKZ9U
Reference: MHGS01A
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960MRQP0435F2

PSR-MRQP04

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960MRQP0435F2
Basic UDI-DI: B-69509960MRQP0435F2
Reference: MRQP04-AOGE
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960MNAP01VYBB

MNAP01-AOGE

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960MNAP01VYBB
Basic UDI-DI: B-69509960MNAP01VYBB
Reference: MNAP01-AOGE
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-5539154038ED-209T42K

ED-209

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: OACP IE LTD
Manufacturer SRN: IE-MF-000003506
UDI-DI: D-5539154038ED-209T42K
Basic UDI-DI: B-5539154038ED-209T42K
Reference: ED-209
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 02:47

Manufacturer products View details

50610078000366

Congenica Rare Disease

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Congenica Ltd
Manufacturer SRN: GB-MF-000026168
UDI-DI: 50610078000366
Basic UDI-DI: B-50610078000366
Reference: 101
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 17.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

Veros COVID-19

CD0004-SP-107

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Sense Biodetection Limited
Manufacturer SRN: GB-MF-000022999
UDI-DI: 50608178000140
Basic UDI-DI: B-50608178000140
Reference: CD0004-SP-107
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:23

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710094

800800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710094
Basic UDI-DI: 888501971800800WU
Reference: 800800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

08809975891017

HysenD30H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891017
Basic UDI-DI: 88099758902007000284
Reference: HysenD30H
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

08809975890034

HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SGRT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240109038
Basic UDI-DI: 924010SG73100KR
Reference: SG73100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

08809378689204

PANAMAX™ 16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689204
Basic UDI-DI: 88093786PNAE200ZR
Reference: PNAE-2001
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

08809378689174

PANAMAX™ 48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689174
Basic UDI-DI: 88093786PNAE100ZL
Reference: PNAE-1001
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Bulgaria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

LQ Suite Droplet Analyzer

TAS-100-5MD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BioTNS Co., Ltd.
Manufacturer SRN: KR-MF-000026409
UDI-DI: 08800271570040
Basic UDI-DI: 8800271578800271570040C6
Reference: TAS-100-5MD
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Amplification Analyzer

AIMDX 1800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Zhunxin Biotechnology
Manufacturer SRN: CN-MF-000028333
UDI-DI: 06976037880004
Basic UDI-DI: 697603788AIMDX1800R4
Reference: INS-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details