- Manufacturer
- Hangzhou Bigfish Bio-tech Co., Ltd.
- Manufacturer SRN
- CN-MF-000027212
- UDI-DI
- 06975514360893
- Basic UDI-DI
- 697551436ThermalcyclerDH
- Reference
- FC-48T
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- -
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 22.07.2026 17:28
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
22.09.2026 01:15
Sync status
Successful
Device
3400347
Actor
47670
Certificate
3311
Sequence
- Manufacturer
- AD Nucleis
- Manufacturer SRN
- FR-MF-000002215
- UDI-DI
- 37604277000578
- Basic UDI-DI
- 376042770SEQUENCE86
- Reference
- SEQ_EVO_IVD
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 22.07.2026 00:48
- Manufacturer
- AD Nucleis
- Manufacturer SRN
- FR-MF-000002215
- UDI-DI
- 37604277000646
- Basic UDI-DI
- 376042770SEQUENCE86
- Reference
- SEQ_PREP_IVD
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 21.07.2026 22:51
myCROBE® Fully Automated Instrument
- 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
myCROBE® Fully Automated Instrument
- 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
HysenD30H
- 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
SGRT
- 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
AIMDX 1800
- 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
Real-time PCR instrument DTlite
- Manufacturer
- DNA-Technology, Research & Production, LLC
- Manufacturer SRN
- RU-MF-000028223
- UDI-DI
- 04660014360512
- Basic UDI-DI
- 466001436DA01ZL
- Reference
- O-DTLITE4S1-EU
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Bulgaria
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 09:30
Real-time PCR instrument DTprime
- Manufacturer
- DNA-Technology, Research & Production, LLC
- Manufacturer SRN
- RU-MF-000028223
- UDI-DI
- 04660014360499
- Basic UDI-DI
- 466001436DA02ZN
- Reference
- O-DTPRIME5M1-EU
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Bulgaria
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 09:30
cobas® eplex system
- Manufacturer
- GenMark Diagnostics
- Manufacturer SRN
- US-MF-000010772
- UDI-DI
- 00857167005382
- Basic UDI-DI
- 085716700510107545001KP
- Reference
- 10107545001
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Netherlands
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 16.07.2026 06:41
ePlex Instrument
- Manufacturer
- GenMark Diagnostics
- Manufacturer SRN
- US-MF-000010772
- UDI-DI
- 00857167005009
- Basic UDI-DI
- 0857167005RM0030017M
- Reference
- RM003001
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Netherlands
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 16.07.2026 06:41
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850049735629
- Basic UDI-DI
- 0850049735AC-61000ET6
- Reference
- AC-61000E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:30
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030650
- Basic UDI-DI
- 0850045030AC-60001E96
- Reference
- AC-60001E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030148
- Basic UDI-DI
- 0850045030AC-60250EAA
- Reference
- AC-60250E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030155
- Basic UDI-DI
- 0850045030AC-60500EA6
- Reference
- AC-60500E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030131
- Basic UDI-DI
- 0850045030AC-60050E9U
- Reference
- AC-60050E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030124
- Basic UDI-DI
- 0850045030AC-60005E9J
- Reference
- AC-60005E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
Device for post-PCR and post-enzymatic reaction clean-up
- Manufacturer
- MagBio Genomics, Inc.
- Manufacturer SRN
- US-MF-000038221
- UDI-DI
- 00850045030056
- Basic UDI-DI
- 0850045030AC-60100E9A
- Reference
- AC-60100E
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Germany
- Authorised representative
- CEpartner4U
- Last updated
- 16.07.2026 06:29
GeneXpert® Infinity Systems
- Manufacturer
- Cepheid
- Manufacturer SRN
- US-MF-000010979
- UDI-DI
- 07332940007713
- Basic UDI-DI
- 081164701-INFINITY-ZH
- Reference
- GX-INFINITY 48S
- EMDN
- W02050116
- EMDN description
- NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
- First on market country
- Netherlands
- Authorised representative
- Cepheid AB
- Last updated
- 16.07.2026 04:13