Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

21.09.2026 21:15

Sync status

Successful

Device

3193421

Actor

47657

Certificate

3311

Filters

Show filters

Active filter:EMDN:W02050116

500 device results listed.

Page 1 / 25

CSV XML

Idylla™ Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000126
Basic UDI-DI: 5415219P0010GM
Reference: P1010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Hub

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219001390
Basic UDI-DI: 5415219P0010GM
Reference: P1030
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000119
Basic UDI-DI: 5415219P0010GM
Reference: P0010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

FilmArray® Torch System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020253
Basic UDI-DI: 357302BUDI000922TZ
Reference: HTFA-ASY-0104
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850544
Basic UDI-DI: 69332898CE3186FW
Reference: WK50
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850575
Basic UDI-DI: 69332898CE3186FW
Reference: WK53
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-1008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850568
Basic UDI-DI: 69332898CE3186FW
Reference: WK52
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850551
Basic UDI-DI: 69332898CE3186FW
Reference: WK51
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551013

Archimed X4

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551013
Basic UDI-DI: 6974795551001CA9
Reference: Archimed X4
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551020

Archimed X6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551020
Basic UDI-DI: 6974795551002CAC
Reference: Archimed X6
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551037

Archimed Mini 16

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551037
Basic UDI-DI: 6974795551003CAF
Reference: Archimed Mini 16
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

GENEQUALITY 2050

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AB ANALITICA srl
Manufacturer SRN: IT-MF-000032625
UDI-DI: 08053303092137
Basic UDI-DI: 803362278GSTRya00000001ZV
Reference: 08-GQ2050-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 05.08.2026 16:32

Manufacturer products View details

MDXlab

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521MDX016F
Basic UDI-DI: B-++M521MDX016F
Reference: MDX01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Greece
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

Procleix Panther System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00850032683609
Basic UDI-DI: 0850032683Panther001B4
Reference: 303160
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 04.08.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570039
Basic UDI-DI: 471987857PCRAC0101RG
Reference: PCRAC0101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo Instrument

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

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570466
Basic UDI-DI: 471987857PCRAC1101RP
Reference: PCRAC1101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

08885019711121

800742

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711121
Basic UDI-DI: 888501971800742X7
Reference: 800742
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710087

800700

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710087
Basic UDI-DI: 888501971800700WP
Reference: 800700
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Viper™ LT System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904428396
Basic UDI-DI: 038290FZFJXEYCFU
Reference: 442839
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 31.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.0 System

Fully Automated Medical PCR Analysis System

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

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702108
Basic UDI-DI: 695629970002NZ
Reference: 505101
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: 31.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details