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111 device results listed.

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LYSUN

FCR-S23（1PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-6971771201979A9
Basic UDI-DI: B-6971771201979A9
Reference: FCR-S23（1PCS）
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:59

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B/COVID-19/ RSV Antigen Rapid Test

Influenza A+B/ COVID-19/ RSV Antigen Rapid Test

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771200859
Basic UDI-DI: B-6971771200859
Reference: Influenza A+B/ COVID-19/ RSV Antigen Rapid Test
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Lithuania
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

Cryostainer

Cryostainer & Accessories

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: ++G580XZELLCryostainerB3R1
Basic UDI-DI: ++G580XZELLCryostainerB3R
Reference: XZ1023
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977254770109

HL-A560

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: Shenzhen Hailife Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042748
UDI-DI: 06977254770109
Basic UDI-DI: B-06977254770109
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

06977254770093

HL-A580

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: Shenzhen Hailife Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042748
UDI-DI: 06977254770093
Basic UDI-DI: B-06977254770093
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

ASFA Scanner

MBD-SC4C-S

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: MBD Co., Ltd.
Manufacturer SRN: KR-MF-000026682
UDI-DI: 08800066300005
Basic UDI-DI: 8800066300005WS
Reference: MBD-SC4C-S
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Javitech Consulting GmbH
Last updated: 03.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

master diagnóstica

VIT-VS42

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: VITRO, S.A.
Manufacturer SRN: ES-MF-000001498
UDI-DI: 08435421271890
Basic UDI-DI: 8435421200571Y8
Reference: VIT-VS42
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:04

Manufacturer products View details

SAGA with Incubator

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287392203
Basic UDI-DI: 843528739220HK
Reference: 6802051
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

SAGA ELISA Microplate Washer

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287392104
Basic UDI-DI: 843528739210HG
Reference: 6802050
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

GEA ELISA Microplate Reader

GEA - Microplate Reader

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287392005
Basic UDI-DI: 843528739200HD
Reference: 6802000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

08435287141016

iPro [IMMUNOFLUORESCENCE PROCESSOR]

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141016
Basic UDI-DI: 8435287191iPRO000000V3
Reference: 84101
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:47

Manufacturer products View details

NOVA View® AUTOLoader

ADLR1000

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950643708
Basic UDI-DI: 84269506437088U
Reference: ADLR1000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

PLATE-WASHER UP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660506
Basic UDI-DI: 805961666PLATEWASHERUP74
Reference: OR-0100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:36

Manufacturer products View details

EVO SYSTEM PLUS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945157701
Basic UDI-DI: 8058945151EVO.01DV
Reference: 1EVO.01
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:16

Manufacturer products View details

BIOHIGH-GRADE

HGL-60V

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing High-Grade Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000051358
UDI-DI: 16979511570009
Basic UDI-DI: 697951157HA001FV
Reference: HGL-60V
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.07.2026 00:50

Manufacturer products Authorised representative products Authorised representative actors View details

SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER

FIC-H0

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06978502842074
Basic UDI-DI: 697850284SZYYQ04NK
Reference: FIC-H0
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Quantum Dot Fluorescence Immunochromatographic Analyzer

J3-E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880263
Basic UDI-DI: 697798188015W
Reference: J3-E
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

DL300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424223219
Basic UDI-DI: 697542422Fluorescence2L
Reference: DL300
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

ST-36W Microplate Washer

ST-96W, ST-98W, ST-36W, ST-36WT, ST-36WF

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847813007
Basic UDI-DI: 697484781006QA
Reference: ST-36W
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Fluorescence Immunoassay Analyzer

Fluorescent Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361115
Basic UDI-DI: 697473536KUA06PE
Reference: FI-620
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details