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08435287108101

[RANDOM ACCESS ANALYZER] A25

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287108101
Basic UDI-DI: 8435287191A2500000007R
Reference: 83101
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:46

Manufacturer products View details

ILab Aries w/o ISE

000160258302

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426950490999
Basic UDI-DI: 8426950490999AB
Reference: 000160258302
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: 03.07.2026 13:05

Manufacturer products View details

Clini5

IVD Class ANot specifiedOn the market

Manufacturer: Callegari S.r.l.
Manufacturer SRN: IT-MF-000035568
UDI-DI: 08057502880014
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: Italy
Authorised representative: -
Last updated: 03.07.2026 11:34

Manufacturer products View details

Pulsar

Pulsar - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401262
Basic UDI-DI: 805360894ES0000553
Reference: ES00005-A
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: 03.07.2026 09:56

Manufacturer products View details

Alcor

Alcor - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401194
Basic UDI-DI: 805360894ES000024V
Reference: ES00002-B
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: 03.07.2026 09:56

Manufacturer products View details

Duo

Duo - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089400968
Basic UDI-DI: 805360894ES000034X
Reference: ES00003-A
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: 03.07.2026 09:56

Manufacturer products View details

Core

Core - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089401026
Basic UDI-DI: 805360894ES000044Z
Reference: ES00004-A
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: 03.07.2026 09:56

Manufacturer products View details

Vchemys

VCS-00P

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

Manufacturer: Voden Medical Instruments S.p.A.
Manufacturer SRN: IT-MF-000029236
UDI-DI: 08033717689994
Basic UDI-DI: 803371768VCHEMYSUK
Reference: VCS-00P
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: 03.07.2026 08:11

Manufacturer products View details

KENZA MAX PLUS BioChemisTry PHOTOMETER

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: BPC Biosed Srl
Manufacturer SRN: IT-MF-000032961
UDI-DI: 08033675433493
Basic UDI-DI: 803367543KM+J7
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: 03.07.2026 08:09

Manufacturer products View details

Automated Biochemistry Analyzer GLOBAL 240

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: 08033675432809
Basic UDI-DI: 803367543GLOB2AF
Reference: 19-0000
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: 03.07.2026 08:09

Manufacturer products View details

CM 160

M-2300

IVD Class AIVDR 2017/746No longer on the marketInstrument

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778043285
Basic UDI-DI: 7791778W02010101011061ZA
Reference: 9351061
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1080

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020372
Basic UDI-DI: 6978848020372HJ
Reference: A00814000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020266
Basic UDI-DI: 6978848020266HJ
Reference: A00813000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020044
Basic UDI-DI: 6978848020044GW
Reference: A00812000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

SMT-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020020
Basic UDI-DI: 6978848020020GG
Reference: A00815000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Biochemical Analyzer

UKCA 2000 / UKCA 3000 / UKCA 6500 / UKCA 8800

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669682209
Basic UDI-DI: 697866968UKCA3S
Reference: UKCA 2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

06978189070050

JIE-100

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

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070050
Basic UDI-DI: 697818907JZCHAWG
Reference: JIE-100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

TECOM

TC6090L, TC6030L, TC220, TC200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tecom Science Corporation
Manufacturer SRN: CN-MF-000038772
UDI-DI: 06977149630006
Basic UDI-DI: 697714963TKACATK
Reference: TC6090L
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

06975838802529

MU500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838802529
Basic UDI-DI: 697583880MS003QU
Reference: HE10015
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemistry Analyzer

MS200

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800631
Basic UDI-DI: 697583880MS200QY
Reference: HE10007
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details