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311 device results listed.

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skyla

HB-P02

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Skyla Corporation Hsinchu Science Park Branch
Manufacturer SRN: TW-MF-000007751
UDI-DI: 04719878650014
Basic UDI-DI: 471987865800-001AVW
Reference: 800-001A
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

Photometer 680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ROBERT RIELE GmbH & Co KG
Manufacturer SRN: DE-MF-000025558
UDI-DI: 04262371610042
Basic UDI-DI: 426237161P68049
Reference: 680003
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:28

Manufacturer products View details

Photometer 505

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ROBERT RIELE GmbH & Co KG
Manufacturer SRN: DE-MF-000025558
UDI-DI: 04262371610035
Basic UDI-DI: 426237161P5053N
Reference: 505001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:28

Manufacturer products View details

Photometer 4040 V5+

Photometer 4040

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ROBERT RIELE GmbH & Co KG
Manufacturer SRN: DE-MF-000025558
UDI-DI: 04262371610028
Basic UDI-DI: 426237161P4040V5+SJ
Reference: 4040001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 23:28

Manufacturer products View details

Photometer 5010 V5+

Photometer 5010

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ROBERT RIELE GmbH & Co KG
Manufacturer SRN: DE-MF-000025558
UDI-DI: 04262371610011
Basic UDI-DI: 426237161P5010V5+S2
Reference: 1704648001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:28

Manufacturer products View details

Photometer 4040+

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ROBERT RIELE GmbH & Co KG
Manufacturer SRN: DE-MF-000025558
UDI-DI: 04262371610004
Basic UDI-DI: 426237161P4040+NN
Reference: 4040044
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:28

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

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 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

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

Access 2 Module, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590742331
Basic UDI-DI: 150995901DxC500iRD
Reference: C13252
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: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

KENZA 240ISE - 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: 03760173087198
Basic UDI-DI: 376017308K2QZ
Reference: KENZA 240ISE
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:10

Manufacturer products View details

Automatic Biochemistry Analyzer

Diag-H200

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996035330
Basic UDI-DI: 69509960Diag-H200DS
Reference: Diag-H200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

GS100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808596
Basic UDI-DI: 69503348GSA002HS
Reference: GS100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details