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

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EXTRALAB

EXTRAlab

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521XLB018J
Basic UDI-DI: B-++M521XLB018J
Reference: XLB01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 22:53

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

BLOTrix System 4/ BLOTrix Reader R2 L

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270577
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrr2l
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

eLab

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521ELB01ZW
Basic UDI-DI: B-++M521ELB01ZW
Reference: ELB01
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Cyprus
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

AMPLIlab

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521ALB01YJ
Basic UDI-DI: B-++M521ALB01YJ
Reference: ALB01
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 22:52

Manufacturer products View details

BOND-ADVANCE Terminal (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005467
Basic UDI-DI: 9349458001D9
Reference: S21.4622
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BOND Controller (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458004859
Basic UDI-DI: 9349458001D9
Reference: S21.4621
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Full Set)

OG-PH05-HLM

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

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056188
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HL-2
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

XEVO TQ-S micro IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020179
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 186007833IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Waters 3777C Sample Manager IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020315
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 725000662IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

ACQUITY UPLC CM-A IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020117
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 186015043IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-FLASH Waste Bottle

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070658
Basic UDI-DI: 84269506397259T
Reference: 3410-0827
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:39

Manufacturer products View details

Tavolo anatomico ad altezza fissa

CT 100 A-F-F

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Comfit Srl
Manufacturer SRN: IT-MF-000055214
UDI-DI: 08051684930017
Basic UDI-DI: 805168493CT100AFFFK
Reference: CT 100 A-F-F
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 22:34

Manufacturer products View details

Tavolo anatomico ad altezza variabile

CT 100 A-F-E

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Comfit Srl
Manufacturer SRN: IT-MF-000055214
UDI-DI: 08051684930000
Basic UDI-DI: 805168493CT100AFEFH
Reference: CT 100 A-F-E
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 22:34

Manufacturer products View details

Decoding Reader for Single Vial

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Biobank Bio-technology Co., Ltd.
Manufacturer SRN: CN-MF-000034142
UDI-DI: 16975638845006
Basic UDI-DI: 697563884BB-RSMQ
Reference: BQ-MS210
EMDN: W02060280
EMDN description: POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 04.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

DNK-MiniCL8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380187
Basic UDI-DI: 697529264012MV
Reference: E105
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

DNK-MiniCL16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380170
Basic UDI-DI: 697529264011MT
Reference: E106
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380033
Basic UDI-DI: 697529264003MU
Reference: E103
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Hunan Biojoint Instrument Co.,Ltd

TD4-PRP, TDD4-MC, TD4-MR, TDZ5-WS, TDZ6-WS, TDZ5-SX, DL-4M, TDL-4MC, DD4-M, TD4ZA, TD4Z-XB, TD4ZB, TD4A-WS, TGD20, DD5-XK, TD4, TD4-ZF, DL-5M, TG18, TG16-WS, TG18-WS, etc

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

Manufacturer: HUNAN BIOJOINT INSTRUMENT CO.,LTD
Manufacturer SRN: CN-MF-000046607
UDI-DI: 06978367200156
Basic UDI-DI: 697836720CentrifugeKV
Reference: DL-4M
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360107

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360107
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details