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Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760180
Basic UDI-DI: 6979469760173M9
Reference: Elf S290
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

Getein 1200 Immunofluorescence Quantitative Analyzer

Getein1200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414713350
Basic UDI-DI: 695441471335HM
Reference: GP1004
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated Blood Grouping System

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802612293
Basic UDI-DI: 69268026BT30000000000018J
Reference: /
EMDN: W0202030102
EMDN description: AUTOMATED BLOOD GROUPING ANALYSERS
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo S920

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049097376
Basic UDI-DI: 697304909Model017FW
Reference: 07092
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 02:25

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AutoLumo S960

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049097383
Basic UDI-DI: 697304909Model017FW
Reference: 07093
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 02:25

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo S980

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049097390
Basic UDI-DI: 697304909Model017FW
Reference: 07094
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 22.09.2026 02:25

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Stainer（BSZ-GR108）

BSJ-DB228

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Baso Diagnostics Inc. Zhuhai
Manufacturer SRN: CN-MF-000050424
UDI-DI: 06952383305798
Basic UDI-DI: 695238330006GM
Reference: BSD-GRI08
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 22.09.2026 02:23

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IDKlia® XL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015326
Basic UDI-DI: 4050598CLIDKlia5V
Reference: CLA1002
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:23

Manufacturer products View details

BioMax

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

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018291398
Basic UDI-DI: 622301829BCAAY
Reference: AD210
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:23

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BioMax

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

Manufacturer: Delta Care for Medical Industries Co, Ltd.
Manufacturer SRN: EG-MF-000044132
UDI-DI: 06223018291411
Basic UDI-DI: 622301829BCAAY
Reference: AD240
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:23

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ALFRED 60/AST

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040140352
Basic UDI-DI: 805604014SI105.100AST3E
Reference: SI 105.100/AST
EMDN: W02039080
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:22

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Tissue-Tek® Cryo3® Specimen Holders, Medium; 6 holders/pack

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233079756
Basic UDI-DI: 06152338267JQ
Reference: 5808
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek® Cryo3® Specimen Holders, Large; 6 holders/pack

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233079763
Basic UDI-DI: 06152338267JQ
Reference: 5809
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 22.09.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Photometer DTN-510K

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: 09120042245120
Basic UDI-DI: 912000735DTNCK
Reference: 212510
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:21

Manufacturer products View details

Photometer DTN-510K

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

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: 09120042245137
Basic UDI-DI: 912000735DTNCK
Reference: 212511
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:20

Manufacturer products View details

00824846004301

Class IMDR 2017/745On the marketActive device

Manufacturer: Medtronic MINIMED
Manufacturer SRN: US-MF-000023100
UDI-DI: 00824846004301
Basic UDI-DI: 0763000B00033638A
Reference: MMT-6101
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

00824846004318

Class IMDR 2017/745On the marketActive device

Manufacturer: Medtronic MINIMED
Manufacturer SRN: US-MF-000023100
UDI-DI: 00824846004318
Basic UDI-DI: 0763000B00033638A
Reference: MMT-6102
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501353

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501353
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SUS
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501339

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501339
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SEU
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

05056393501346

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

Manufacturer: Abbott Toxicology Ltd
Manufacturer SRN: GB-MF-000001885
UDI-DI: 05056393501346
Basic UDI-DI: 50563935TOX0001QY
Reference: TOX400SUK
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: -
Authorised representative: Abbott Rapid Dx International Limited
Last updated: 22.09.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details