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XL-640 with ISE

XL-640

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143196
Basic UDI-DI: 8592156CCIN0052SJ
Reference: INS00007
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL-200 with ISE

XL-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143189
Basic UDI-DI: 8592156CCIN0051SG
Reference: INS00001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL -180 with ISE

XL -180

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143158
Basic UDI-DI: 8592156CCIN0050SE
Reference: INS00037
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

CHEM-7

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156098977
Basic UDI-DI: 8592156CCIN0056SS
Reference: INS00014
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

SPIN XL

Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673019235
Basic UDI-DI: 8431673INTF02WM
Reference: 5004100
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: 16.07.2026 12:12

Manufacturer products View details

ACTION

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660346
Basic UDI-DI: 805961666ACTIONJW
Reference: OR-9711510
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Portugal
Authorised representative: -
Last updated: 16.07.2026 12:11

Manufacturer products View details

SENTiFIT® 300 Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer SRN: IT-MF-000012556
UDI-DI: 08058056685636
Basic UDI-DI: 805805668CIS30003I1235AJ4
Reference: 550300
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:09

Manufacturer products View details

AUTOANALYZER MOD. MIURA ONE (9 Smp Pos) p/n 10750-00-A

AUTOANALYZER MOD. MIURA ONE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510409
Basic UDI-DI: 803380351BCAAMIURAONE014X
Reference: I3310001210
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA DA (79 Smp Pos) p/n 10001-01-A

AUTOANALYZER MOD. MIURA DA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510362
Basic UDI-DI: 803380351BCAAMIURADA001T4
Reference: I3260011206
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA 200 SA (31 Rgt Pos) p/n 11025-00-A

AUTOANALYZER MOD. MIURA 200 SA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510249
Basic UDI-DI: 803380351BCAAM200SA000173
Reference: I3320001201-E
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. MIURA 200 DA (31 Rgt Pos) p/n 10997-00-A

AUTOANALYZER MOD. MIURA 200 DA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510201
Basic UDI-DI: 803380351BCAAM200DA0001YV
Reference: I3320001221
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
Manufacturer SRN: IT-MF-000028898
UDI-DI: 08033803510195
Basic UDI-DI: 803380351BCAAHEMOONE001PC
Reference: I3330000001
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:47

Manufacturer products View details

NIOX PRO

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

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030724
Basic UDI-DI: 735004703NIOXPROMZ
Reference: 20-1000
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

NIOX

NIOX Sensor

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030267
Basic UDI-DI: 735004703NIOXSENSORG2
Reference: 12-1610
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

NIOX

NIOX Breathing Handle

IVD Class BIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testing

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030175
Basic UDI-DI: 735004703NIOXHANDLE6R
Reference: 12-1010
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

06979845480114

ACA820

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Hunan Runmei Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000017635
UDI-DI: 06979845480114
Basic UDI-DI: 697984548ACA820PC
Reference: RM-R03-013-1.0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Test Reader

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

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: 06978274250008
Basic UDI-DI: 6978274250000DG
Reference: aca-A01
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230673

Uric Acid Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230673
Basic UDI-DI: 697733823000KDY
Reference: C21-UAA100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230659

Glucose/Ketone/Uric Acid/Total Cholesterol Analyzer Pro

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230659
Basic UDI-DI: 697733823000GDQ
Reference: C21-GKUC200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230642

Rapid Test Reader - for Urine Test Cup

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230642
Basic UDI-DI: 697733823000IDU
Reference: L21-LR200
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details