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08885019711299

800580

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711299
Basic UDI-DI: 888501971800580X5
Reference: 800580
EMDN: W02070403
EMDN description: HOMOGENIZERS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid-OR³ System check cartridge

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133013014
Basic UDI-DI: 880613305170CY
Reference: FPCC216
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid-OR³

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010648
Basic UDI-DI: 880613301064C4
Reference: FPRR040-11
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Accessory Box

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771102902
Basic UDI-DI: 8056771MOL1100TP
Reference: MOL1100
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 21:38

Manufacturer products View details

08033629924534

Software Genetic Fragment Analyzer V1.5

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924534
Basic UDI-DI: 803362992DO021A2U
Reference: DO021/A
EMDN: W02079082
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 21:36

Manufacturer products View details

Urine Analyzer

EXU 300, EXU 500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221685
Basic UDI-DI: 69732628600134ZU
Reference: 1200507
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

00841007007643

Fluorescence Immunoassay Analyzer

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

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: 00841007007643
Basic UDI-DI: 84100700000O5Y
Reference: CTA-FAH
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380523

LiCA Smart

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380523
Basic UDI-DI: 6973864380104EH
Reference: 04090113000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

06973864382923

LiCA PT 1000

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864382923
Basic UDI-DI: 6973864380106EM
Reference: 04090115300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221715
Basic UDI-DI: 69732628600134ZU
Reference: 1200510
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 21.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

VITROS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ortho Clinical Diagnostics Biotechnology Development (Shanghai) Co., Ltd
Manufacturer SRN: CN-MF-000053560
UDI-DI: 06975608040007
Basic UDI-DI: 6975608040007AV
Reference: 6204444
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Romania
Authorised representative: Ortho-Clinical Diagnostics France
Last updated: 21.09.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Refrigerator

Class IMDR 2017/745On the marketActive device

Manufacturer: Jinan Biobase Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000027133
UDI-DI: 06974738685621
Basic UDI-DI: 697473868XBX001XP
Reference: BBR-4V466
EMDN: W020702
EMDN description: CRYOGENICS / FROZEN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 21.09.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

CA-101

CD12-1-17

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110057
Basic UDI-DI: 4051088CD12X173Y
Reference: 114-99-050-xx
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 21:28

Manufacturer products View details

Xevo TQ-XS IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020346
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 186008453IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

S/W w_connect base kit v. 3.2.0 LTS

Waters IVD Systems

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020698
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 667007225DD
EMDN: W020303
EMDN description: MASS - SPECTROMETRY SYSTEM
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

CoaDATA 2004

CD12-1-17

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110064
Basic UDI-DI: 4051088CD12X173Y
Reference: 112-99-130-xx
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Romania
Authorised representative: -
Last updated: 21.09.2026 21:27

Manufacturer products View details

Portable Multi-Function Analyzer

DP-H50 Pro

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377308778
Basic UDI-DI: 697049309W02020000004A8
Reference: PO-0032-01
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 21.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoassay System AURYX 90

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600304
Basic UDI-DI: 59075146AURYX90ZQ
Reference: I20-A0001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: -
Last updated: 21.09.2026 21:26

Manufacturer products View details

biobas 20

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110071
Basic UDI-DI: 4051088CD12X173Y
Reference: 5003010
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:26

Manufacturer products View details

CoaDATA 4004

CD12-1-17

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110088
Basic UDI-DI: 4051088CD12X173Y
Reference: 112-99-090-xx
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 21:25

Manufacturer products View details