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Atellica DL

IVDR_67_TTN_DUB-C_A_INST_DL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002347
Basic UDI-DI: 0405686902026V3
Reference: 11068008
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Chemichroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010532
Basic UDI-DI: 880613301053BX
Reference: FPRR058
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

XL-1000 with ISE

XL-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143219
Basic UDI-DI: 8592156CCIN0053SL
Reference: INS00009
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

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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

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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

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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

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

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

06973316740325

Speedry Chem

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740325
Basic UDI-DI: 697331674DBA00029S
Reference: 68000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

AILEX

AS-690

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

Manufacturer: Ailex Technology Group Co., Ltd.
Manufacturer SRN: CN-MF-000018920
UDI-DI: 06970133922996
Basic UDI-DI: 697013392002FE
Reference: LY-MY-SH-03997
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

AILEX

AS-1450

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

Manufacturer: Ailex Technology Group Co., Ltd.
Manufacturer SRN: CN-MF-000018920
UDI-DI: 06970133922972
Basic UDI-DI: 697013392003FG
Reference: LY-MY-SH-03998
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674860006
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer ACCENT-400

ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601691
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:21

Manufacturer products View details

05600717621045

H1000

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: LABINLIGHT, LDA
Manufacturer SRN: PT-MF-000034199
UDI-DI: 05600717621045
Basic UDI-DI: 5600717621CARTDRIGE94
Reference: H100100
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Portugal
Authorised representative: -
Last updated: 16.07.2026 10:01

Manufacturer products View details

FUJI PLAIN TUBE

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282798
Basic UDI-DI: 454741030100000000000436U
Reference: 04902520282798
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI HEPARIN TUBE

IVD Class AIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282767
Basic UDI-DI: 454741030100000000000426S
Reference: 04902520282767
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI DRI-CHEM MIXING CUPS S

FUJI DRI-CHEM MIXING CUPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282620
Basic UDI-DI: 4547410301000000000003975
Reference: 04902520282620
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

08033622965046

AUTOLYSER 450

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622965046
Basic UDI-DI: 0803362296504TZ
Reference: AUTOLYSER 450
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 03:30

Manufacturer products View details

08033622964988

BT 3700

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964988
Basic UDI-DI: 0803362296498UX
Reference: BT 3700I
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: 16.07.2026 03:30

Manufacturer products View details

BT 3700

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964964
Basic UDI-DI: 0803362296496UT
Reference: BT 3700
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: 16.07.2026 03:30

Manufacturer products View details