- Manufacturer
- Shanghai Medconn Medical Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000038658
- UDI-DI
- 06954417600329
- Basic UDI-DI
- 695441761107R832
- Reference
- NA
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Netherlands
- Authorised representative
- JOYSUN GROUP S.L.U
- Last updated
- 17.07.2026 23:48
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
24.09.2026 16:37
Sync status
Successful
Device
3609577
Actor
47882
Certificate
3409
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Shanghai Medconn Medical Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000038658
- UDI-DI
- 06954417600411
- Basic UDI-DI
- 695441761110RA2N
- Reference
- NA
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Netherlands
- Authorised representative
- JOYSUN GROUP S.L.U
- Last updated
- 17.07.2026 07:09
EZ POC System check cartridge
EZ POC System check cartridge
IVD Class AIVDR 2017/746On the marketKitProfessional testing
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133090633
- Basic UDI-DI
- 880613309063DS
- Reference
- FPCC154
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Austria
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:44
ez-Tracker System check cartridge
ez-Tracker System check cartridge
IVD Class AIVDR 2017/746On the marketProfessional testing
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133081389
- Basic UDI-DI
- 880613308138DR
- Reference
- ET001-SC
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:44
QDx Instacheck™ System check cartridge
QDx Instacheck™ System check cartridge
IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133081488
- Basic UDI-DI
- 880613308148DU
- Reference
- FPCC156
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Poland
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:44
ichroma™ System check cartridge
ichroma™ System check cartridge
IVD Class AIVDR 2017/746On the marketKitProfessional testing
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133030172
- Basic UDI-DI
- 880613303017C9
- Reference
- FPCC152
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Poland
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:43
AFIAS System check cartridge
AFIAS System check cartridge
IVD Class AIVDR 2017/746On the marketKitProfessional testing
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133006412
- Basic UDI-DI
- 880613300641CF
- Reference
- FPCC128
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- France
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:43
AFIAS Washing Cartridge
AFIAS Washing Cartridge
IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133005392
- Basic UDI-DI
- 880613300594CX
- Reference
- SMFP-79
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Italy
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:43
ichroma™ M2 System check cartridge
ichroma™ M2 System check cartridge
IVD Class AIVDR 2017/746On the marketKitProfessional testing
- Manufacturer
- Boditech Med Inc.
- Manufacturer SRN
- KR-MF-000011028
- UDI-DI
- 08806133001578
- Basic UDI-DI
- 880613300157C5
- Reference
- FPCC170
- EMDN
- W0201020180
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Poland
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 12:42
ACTION
ACTION
IVD Class AIVDR 2017/746On the marketProfessional testing
- Manufacturer
- DAS Srl
- Manufacturer SRN
- IT-MF-000035583
- UDI-DI
- 08059616660346
- Basic UDI-DI
- 805961666ACTIONJW
- Reference
- OR-9711510
- EMDN
- W0201020182
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
- First on market country
- Portugal
- Authorised representative
- -
- Last updated
- 16.07.2026 12:11
06977338230055
Automatic Chemiluminescence Immunoassay Analyzer
IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
- Manufacturer
- Newlink Biotech co., Ltd.
- Manufacturer SRN
- CN-MF-000045176
- UDI-DI
- 06977338230055
- Basic UDI-DI
- 697733823000JDW
- Reference
- G21-CA101
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Spain
- Authorised representative
- VidaQuick Biotech S.L.
- Last updated
- 16.07.2026 11:21
Auto Chemiluminescence Analyzer
MT120S, MT120
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Genrui Biotech Inc.
- Manufacturer SRN
- CN-MF-000017351
- UDI-DI
- 06950334825043
- Basic UDI-DI
- 69503348MTA008LX
- Reference
- MT120S
- EMDN
- W0201020102
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
- First on market country
- Türkiye
- Authorised representative
- Lotus NL B.V.
- Last updated
- 16.07.2026 10:47
HM-JACKarcⅡ
HM-JACKarcⅡ
IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing
- Manufacturer
- Canon Medical Diagnostics Corporation
- Manufacturer SRN
- JP-MF-000020364
- UDI-DI
- 04987295657873
- Basic UDI-DI
- 4987295BU002ZT
- Reference
- 65787
- EMDN
- W0201020102
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
- First on market country
- Spain
- Authorised representative
- Obelis s.a.
- Last updated
- 16.07.2026 09:40
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- General Biologicals Corporation
- Manufacturer SRN
- TW-MF-000024694
- UDI-DI
- 04712803533789
- Basic UDI-DI
- 4712803534MGCLI120JP
- Reference
- 4MGCLI120
- EMDN
- W0201020102
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 16.07.2026 09:31
SPINCHIP® SOFTWARE
SPINCHIP® SOFTWARE
IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
- Manufacturer
- bioMérieux SA
- Manufacturer SRN
- FR-MF-000004436
- UDI-DI
- 03573026646530
- Basic UDI-DI
- 357302BUDI002311TC
- Reference
- 425376
- EMDN
- W0201020182
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
- First on market country
- France
- Authorised representative
- -
- Last updated
- 16.07.2026 07:51
SpinChip SampleTransfer
SpinChip SampleTransfer
IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- bioMérieux SA
- Manufacturer SRN
- FR-MF-000004436
- UDI-DI
- 03573026646127
- Basic UDI-DI
- 357302BUDI002312TE
- Reference
- 543799
- EMDN
- W0201020185
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
- First on market country
- France
- Authorised representative
- -
- Last updated
- 16.07.2026 07:51
FIAPresto FIAVet
FIAPresto™, FIAPresto™II, FIAPresto™III, FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Bifour Biotech Inc.
- Manufacturer SRN
- US-MF-000034957
- UDI-DI
- 00860010246207
- Basic UDI-DI
- 08600102462BBIITRI001AN
- Reference
- FIAPresto™, FIAPresto™II, FIAPresto™III, FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
- EMDN
- W0201020192
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 16.07.2026 06:53
Wash Buffer
NOVEOS® Immunoassay System Accessories
IVD Class AIVDR 2017/746On the marketProfessional testing
- Manufacturer
- Hycor Biomedical LLC
- Manufacturer SRN
- US-MF-000031449
- UDI-DI
- 00816879023046
- Basic UDI-DI
- 081687902NOVACCKX
- Reference
- 63165
- EMDN
- W0201020185
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
- First on market country
- Germany
- Authorised representative
- Advena Limited
- Last updated
- 16.07.2026 04:23
NOVEOS® Immunoassay System
NOVEOS® Immunoassay System
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Hycor Biomedical LLC
- Manufacturer SRN
- US-MF-000031449
- UDI-DI
- 00816879022995
- Basic UDI-DI
- 081687902NOVINST37
- Reference
- 63000
- EMDN
- W0201020192
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
- First on market country
- France
- Authorised representative
- Advena Limited
- Last updated
- 16.07.2026 04:23
00816870024448
IN006-3
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Monobind Inc.
- Manufacturer SRN
- US-MF-000021611
- UDI-DI
- 00816870024448
- Basic UDI-DI
- 081687002IN006-3UR
- Reference
- IN006-3
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Netherlands
- Authorised representative
- AR Experts B.V.
- Last updated
- 16.07.2026 04:23