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URYXXON® 500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MACHEREY-NAGEL GmbH & Co. KG
Manufacturer SRN: DE-MF-000005636
UDI-DI: 04046681090721
Basic UDI-DI: 4046681151866XK
Reference: 930080
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:16

Manufacturer products View details

BIOCHEMISTRY ANALYZER AX-300OPEN

AX300OPEN, AX300CLOSED, AX400OPEN, AX400CLOSED

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GMT SARL
Manufacturer SRN: FR-MF-000025248
UDI-DI: 03770028922130
Basic UDI-DI: 3770028922AX000TC
Reference: AX300
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:10

Manufacturer products View details

BIOCHEMISTRY ANALYZER AX - 200OPEN

AX200OPEN, AX200CLOSED

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GMT SARL
Manufacturer SRN: FR-MF-000025248
UDI-DI: 03770028922123
Basic UDI-DI: 3770028922AX200TN
Reference: AX200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:10

Manufacturer products View details

Uriki

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

Manufacturer: Iki
Manufacturer SRN: FR-MF-000023181
UDI-DI: 03770027558019
Basic UDI-DI: 3770027558UrikiPY
Reference: Uriki
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

My Uriki

IVD Class AIVDR 2017/746On the marketNear-patient testing

Manufacturer: Iki
Manufacturer SRN: FR-MF-000023181
UDI-DI: 03770027558002
Basic UDI-DI: 3770027558MyUrikiSQ
Reference: My Uriki
EMDN: W020101020182
EMDN description: AUTOMATED URINE ANALYSERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories

KENZA ONE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087372
Basic UDI-DI: 376017308K1QX
Reference: KENZA ONE
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 15:15

Manufacturer products 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

KENZA 240TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories

KENZA 240TX

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087181
Basic UDI-DI: 376017308K2QZ
Reference: KENZA 240TX
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 15:15

Manufacturer products View details

KENZA MAX BioChemisTry PHOTOMETER

KENZA MAX BioChemisTry PHOTOMETRE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BIOLABO
Manufacturer SRN: FR-MF-000001633
UDI-DI: 03760173087006
Basic UDI-DI: 376017308KMSM
Reference: KENZA MAX
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 15:15

Manufacturer products View details

DxC 500 AU Module, DxC 500i

DxC 500i Clinical Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666545072
Basic UDI-DI: 150995901DxC500iRD
Reference: C63521
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

DxC 500 AU Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666545058
Basic UDI-DI: 150995901DxC500AUZM
Reference: C63519
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU5800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666543016
Basic UDI-DI: 150995901AU58003W
Reference: B96697
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542989
Basic UDI-DI: 150995901AU6805P
Reference: B96694
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU480

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542965
Basic UDI-DI: 150995901AU4805D
Reference: B96692
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

CHEMISTRY ANALYZER DxC 700 AU

Beckman Coulter DxC 700 AU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542491
Basic UDI-DI: 150995901DxC700AU2E
Reference: B86443
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

DxC 500 AU Module w/ ISE, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666545089
Basic UDI-DI: 150995901DxC500iRD
Reference: C63522
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

80575028800018

IVD Class ANot specifiedOn the market

Manufacturer: Callegari S.r.l.
Manufacturer SRN: IT-MF-000035568
UDI-DI: 80575028800018
Basic UDI-DI: 805750288000139
Reference: 126181P
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 30.06.2026 22:47

Manufacturer products View details

Portable Biochemical Analyzer

H300-D

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

Manufacturer: Shenzhen Tailaored Medical .Ltd
Manufacturer SRN: CN-MF-000029307
UDI-DI: 06970879394620
Basic UDI-DI: 697087939HD000KA
Reference: H300-D
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors 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

Chemistry Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053016223
Basic UDI-DI: 69449040SHYQ-BA6M******4T
Reference: BS-620M
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details