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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

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

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

06936268412382

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Manufacturer SRN: CN-MF-000036494
UDI-DI: 06936268412382
Basic UDI-DI: B-06936268412382
Reference: 1062630
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.09.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution

BG-01

IVD Class CIVDR 2017/746On the marketDirect markingReagentSelf testingSingle use

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040113676
Basic UDI-DI: 69450401BG01JW
Reference: BG-01
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): EU250806-SSP · Rev. C
Authorised representative: Prolinx GmbH
Last updated: 24.09.2026 05:42

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

FE Focus B

1×10mL, 1×60mL, 1×125mL

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202245640
Basic UDI-DI: 69422022W0101909902R0VF
Reference: 3026994
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.09.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control Solution for Urine Analyzer

URIT YQ 3STC、UNAMAX SG Control、UNAMAX COLOR Control、UNAMAX TURBIDITY Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740754415
Basic UDI-DI: 69357407IUCS000005QU
Reference: /
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.09.2026 05:31

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

UQ-14、UQ-13、UQ-11、UQ-10

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740754286
Basic UDI-DI: 69357407IUCS000002QN
Reference: USUC00001074
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.09.2026 05:31

Manufacturer products Authorised representative products Authorised representative actors View details

RAPIDLab® 348EX pH Electrode Fill

IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX

IVD Class CIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414115269
Basic UDI-DI: 0405686901946WF
Reference: 10311046
EMDN: W0101060606
EMDN description: BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE
First on market country: Germany
Safety summary (SSCP/SSP): DX026402 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 04:59

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

RAPIDLab 348X 6.8/7.3 Buffer (Japan)

IVD Class CIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414495989
Basic UDI-DI: 0405686901946WF
Reference: 10336723
EMDN: W0101060606
EMDN description: BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE
First on market country: -
Safety summary (SSCP/SSP): DX026402 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 04:57

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

RAPIDLab® Reference Electrode Fill

IVD Class CIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414117539
Basic UDI-DI: 0405686901946WF
Reference: 10311081
EMDN: W0101060606
EMDN description: BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE
First on market country: -
Safety summary (SSCP/SSP): DX026402 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 04:56

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

NEONATAL PKU Screening Assay

E-IW

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430002471716
Basic UDI-DI: 5430002471E-IW-DL
Reference: E-IW-288
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Belgium
Authorised representative: -
Last updated: 24.09.2026 04:45

Manufacturer products View details

LC-MS/MS Reagent Kit MassTox® Immunosuppressants in whole blood ONEMINUTE Test

MassTox® Immunosuppressants in whole blood

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317557841
Basic UDI-DI: 4250317930006C
Reference: 93900/1200/DWP
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:03

Manufacturer products View details

Stabilisation Reagent

Catecholamines in urine

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317526380
Basic UDI-DI: 42503176000C5S
Reference: 6010/COMBI
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:03

Manufacturer products View details

Hepcidin-25 LC-MS/MS

iron metabolism

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598012684
Basic UDI-DI: 4050598CMFEXA
Reference: YM4000
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 03:59

Manufacturer products View details

Novacheck Blood Glucose Test Strips

Blood Glucose Test Strips

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testingSingle use

Manufacturer: NOVATECH TIBBİ CİHAZ ÜRÜNLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019017
UDI-DI: 08682328782015
Basic UDI-DI: B-08682328782015
Reference: NV-2701
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Authorised representative: -
Last updated: 24.09.2026 03:57

Manufacturer products View details

VITROS Chemistry Products ALBp Slides

VITROS

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Ortho-Clinical Diagnostics, Inc. Rochester
Manufacturer SRN: US-MF-000009352
UDI-DI: 10758750036165
Basic UDI-DI: 10758750036189MW
Reference: 6811212
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: France
Authorised representative: Ortho-Clinical Diagnostics France
Last updated: 24.09.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details