- 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
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
18.09.2026 17:42
Sync status
Successful
Device
3108040
Actor
47631
Certificate
3283
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
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
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
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
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
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
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
GENEQUALITY 2050
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
MDXlab
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
Procleix Panther System
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
VitaPCR Instrument
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
VitaSIRO solo Instrument
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
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
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
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
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
Nucleic Acid Extraction System
Nucleic Acid Extraction System
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000013246
- UDI-DI
- 06956299702030
- Basic UDI-DI
- 695629970003P3
- Reference
- 501110
- 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
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- Manufacturer SRN
- CN-MF-000013666
- UDI-DI
- 06955931304250
- Basic UDI-DI
- 695593130023090804MC
- Reference
- 2309HD
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Italy
- Authorised representative
- Obelis s.a.
- Last updated
- 31.07.2026 20:29
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- Manufacturer SRN
- CN-MF-000013666
- UDI-DI
- 06955931304243
- Basic UDI-DI
- 695593130023080807M7
- Reference
- 2308HG
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Italy
- Authorised representative
- Obelis s.a.
- Last updated
- 31.07.2026 20:29
Automatic Nucleic Acid Extraction System
Automatic Nucleic Acid Extraction System
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Biobase Biodustry(Shandong) Co.,Ltd.
- Manufacturer SRN
- CN-MF-000025015
- UDI-DI
- 06936895300120
- Basic UDI-DI
- 6936895BS0082G
- Reference
- BS008
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- Luxus Lebenswelt GmbH
- Last updated
- 31.07.2026 19:00