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123 device results listed.

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careHPV Test Luminometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228048015
Basic UDI-DI: 4053228ICARELUM0000000128
Reference: 9001773
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

RapiCycler 96 Real Time PCR System (4-Channel)

G2MRAPI4001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200087
Basic UDI-DI: 890617820G2MRAPI4001CV
Reference: G2MRAPI4001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System-(6-Channel)

G2MRAPI4002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200094
Basic UDI-DI: 890617820G2MRAPI4002CX
Reference: G2MRAPI4002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242239

EXM 3000 Duo

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242239
Basic UDI-DI: 697326286002672K
Reference: 0307402
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ301 Sequencer

690025

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013950045
Basic UDI-DI: 888501395SSQ301P2E
Reference: 400103
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

croGENE Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696305772
Basic UDI-DI: 859569630077R4
Reference: CGRT6/96
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

Promotor 960 Real-Time PCR System

RTQ-960

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756498122
Basic UDI-DI: 6921756499990012WU
Reference: P111-2011-201
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

PEBBLE qcLAMP Platform

Pebble qcLAMP Platform

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

Manufacturer: BIOPIX DNA TECHNOLOGY P.C.
Manufacturer SRN: GR-MF-000033590
UDI-DI: 05210166000027
Basic UDI-DI: 5210166000057M3
Reference: 000057
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:45

Manufacturer products View details

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

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

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-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

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

Automated Nucleic Acid Purification System

PureStar-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341686871
Basic UDI-DI: 6970341680120801HN
Reference: 0120801
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

00860010246221

NAE 2 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246221
Basic UDI-DI: 08600102462NucleicAcidVQ
Reference: NAE 2 PLUS
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

00860010246214

KadieCheck® Pro Max

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246214
Basic UDI-DI: 08600102462PCRL9
Reference: KadieCheck® Pro Max
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Fluxergy Analyzer

Mk12.1

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

Manufacturer: Fluxergy Inc.
Manufacturer SRN: US-MF-000010833
UDI-DI: 00850027856124
Basic UDI-DI: 0850027856MkD6W
Reference: 5506-CE
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details