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CA 100

CALCIUM

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156080545
Basic UDI-DI: 8592156CCRE0039TC
Reference: BLT00015
EMDN: W01010303
EMDN description: CALCIUM
First on market country: Czechia
Authorised representative: -
Last updated: 24.09.2026 07:33

Manufacturer products View details

CHOL 440

CHOLESTEROL

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156079709
Basic UDI-DI: 8592156CCRE0020SP
Reference: XSYS0009
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Czechia
Authorised representative: -
Last updated: 24.09.2026 07:32

Manufacturer products View details

GGT 110

GAMMAGLUTAMYLTRANSFERASE

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156079693
Basic UDI-DI: 8592156CCRE0010SL
Reference: XSYS0011
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Czechia
Authorised representative: -
Last updated: 24.09.2026 07:32

Manufacturer products View details

ALP 110

ALKALINE PHOSPHATASE

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156079662
Basic UDI-DI: 8592156CCRE0002SM
Reference: XSYS0002
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Czechia
Authorised representative: -
Last updated: 24.09.2026 07:32

Manufacturer products View details

Ready Sensor Lactate Biosensor (4 pack)

IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-RapidLab1200

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414112350
Basic UDI-DI: 0405686901967WP
Reference: 10311032
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Safety summary (SSCP/SSP): DX026393 · Rev. D
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

RAPIDLab® 1200 Series CO-ox Sample Chamber

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414492629
Basic UDI-DI: 0405686901967WP
Reference: 10324165
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: -
Safety summary (SSCP/SSP): DX026393 · Rev. D
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08056138338937

Gepotidacin GEP 10 µg

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Liofilchem S.r.l.
Manufacturer SRN: IT-MF-000026495
UDI-DI: 08056138338937
Basic UDI-DI: 805518287ATBDISC256Z9
Reference: 9256/1
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:22

Manufacturer products View details

LATEX CONTROLS

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040140024
Basic UDI-DI: 805604014SI305.X0X-A7S
Reference: SI 305.102-A
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:22

Manufacturer products View details

RAPIDLab® 1200 pH Electrode Fill

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414570495
Basic UDI-DI: 0405686901967WP
Reference: 10376881
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: -
Safety summary (SSCP/SSP): DX026393 · Rev. D
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

08055182874576

Amikacin AK 30 µg

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Liofilchem S.r.l.
Manufacturer SRN: IT-MF-000026495
UDI-DI: 08055182874576
Basic UDI-DI: 805518287ATBDISC004YC
Reference: 9004/1
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:22

Manufacturer products View details

RAPIDLab® 1200 Systems Reagent Cartridge

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414492605
Basic UDI-DI: 0405686901967WP
Reference: 10319811
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: -
Safety summary (SSCP/SSP): DX026393 · Rev. D
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 07:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Quantia D-Dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 00380740174187
Basic UDI-DI: 8436003070542XH
Reference: 7K02-02
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 24.09.2026 07:19

Manufacturer products View details

MILEGREEN

Clearing reagents

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: MILESTONE S.P.A.
Manufacturer SRN: IT-MF-000024414
UDI-DI: 08052478983523
Basic UDI-DI: 805247898CLEARING6Z
Reference: 51417
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:13

Manufacturer products View details

HHV8 ELITe MGB® Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483968
Basic UDI-DI: 803389148HHV25CP
Reference: RTS038PLD
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

Manufacturer products View details

HHV6 - ELITe Positive Control

HHV6 ELITe MGB® Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483517
Basic UDI-DI: 803389148HHV39D2
Reference: CTR036PLD
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

Manufacturer products View details

AMPLIQUALITY HCV TYPE PLUS

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: AB ANALITICA srl
Manufacturer SRN: IT-MF-000032625
UDI-DI: 08033622784470
Basic UDI-DI: 803362278AINFrk00000000T5
Reference: 03-05-XX
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

Manufacturer products View details

Fast Fluorescence In Situ Hybridization Probe Kit

MYC(8q24)/BCL6(3q27)/BCL2(18q21) gene break apart probe reagent

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: 06971808257429
Basic UDI-DI: 697180825KFP243HN
Reference: FP-243-2
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 24.09.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

BD LEUCOCOUNT

BD Leucocount Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903410019
Basic UDI-DI: 038290BDMJNRFX3Z
Reference: 341001
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

BD MULTI-CHECK

BD Multi-Check Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903409112
Basic UDI-DI: 038290DYCWQUCGGJ
Reference: 340911
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

BD LEUCOCOUNT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903410033
Basic UDI-DI: 038290BDMJNRFX3Z
Reference: 341003
EMDN: W0103080402
EMDN description: LEUCOCYTE CONTROLS
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 24.09.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details