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89 device results listed.

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LIDA 500 Automatic Clinical Chemistry Analyzer

LIDA-500 Automatic Clinical Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393408
Basic UDI-DI: 843528739340HW
Reference: 1805500
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

08435287101317

[AUTOANALYZER] BA400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287101317
Basic UDI-DI: 8435287191BA40000000J5
Reference: 83400
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

ILab Taurus refurbished w/o ISE 230V

00001070301R

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951273485
Basic UDI-DI: 84269512734858V
Reference: 00001070301R
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 13:14

Manufacturer products View details

ILab Taurus with ISE 230V

00001070302

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426950657552
Basic UDI-DI: 84269506575529U
Reference: 00001070302
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 13:11

Manufacturer products View details

ILab Taurus without ISE 230V

00001070301

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426950657545
Basic UDI-DI: 84269506575459X
Reference: 00001070301
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 13:11

Manufacturer products View details

Automated Biochemistry Analyzer GLOBAL 4500DR

Automated Biochemistry Analyzer > 400 tests/h

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BPC Biosed Srl
Manufacturer SRN: IT-MF-000032961
UDI-DI: 08033675433394
Basic UDI-DI: 803367543GLOB4AK
Reference: 22-0000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:09

Manufacturer products View details

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630946327
Basic UDI-DI: 761333601501A7
Reference: 07649142001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601707
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0002
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:41

Manufacturer products View details

Vivadiag

LP-101/LP-102

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

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630663
Basic UDI-DI: 6975519630001B5C
Reference: LC-103-1/LC-113-1
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:14

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemistry Analyzer

MS-420P,MS-400P,MS-380P,MS-420,MS-400,MS-380,MS-480,MS-450,MS-520,MS-600,MS-680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ningbo MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014369
UDI-DI: 06975096610058
Basic UDI-DI: 697509661MSC001P5
Reference: MS380P
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06973861681630

SHA-100, SHA-200

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681630
Basic UDI-DI: 6973861681630F6
Reference: SHA-100, SHA-200
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151050

BC-600

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

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151050
Basic UDI-DI: 697360915105KM
Reference: （01）6973609151050（11）210113（21）5A52021001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740196

Speedry Chem

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740196
Basic UDI-DI: 697331674DBA00029S
Reference: A311011
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242284

EXC460, EXC470

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242284
Basic UDI-DI: 6973262860014626
Reference: 0112804
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-8400 Automatic Chemistry Analyzer

URIT-8031、URIT-8210、URIT-8400、URIT-8460、CA-220、CA-431A、CA-431B、CA-200、CA-641A、CA-641B、CA-641C、CA-150、CA-160、CA-180、CA-351A、CA-351B、CA-351C、CA-431C、URIT-8060、URIT-8030、URIT-8121A、URIT-8131、URIT-8136、CA-331A,etc

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740718776
Basic UDI-DI: 69357407ICA000002K5
Reference: /
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-8460 Automatic Chemistry Analyzer

URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740718769
Basic UDI-DI: 69357407ICA000001K3
Reference: /
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

KENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories

KENZA 450TX

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087204
Basic UDI-DI: 376017308K4R5
Reference: KENZA 450TX
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 15:15

Manufacturer products View details

Portable Biochemical Analyzer

AUSA 340II-T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Tailaored Medical .Ltd
Manufacturer SRN: CN-MF-000029307
UDI-DI: 06970879393098
Basic UDI-DI: 697087939PC000MT
Reference: AUSA 340II-T
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087211
Basic UDI-DI: 376017308K4R5
Reference: KENZA 450ISE
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:10

Manufacturer products View details

SERUM CUPS K450

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087273
Basic UDI-DI: 376017308K4R5
Reference: CO0058
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:10

Manufacturer products View details