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Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047989004
Basic UDI-DI: 0810047980012AGD
Reference: ACA402r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186848507
Basic UDI-DI: 0810047980012AGD
Reference: ACA402r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

N Evaporation Caps for Reagent Vials (5 ml)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012303
Basic UDI-DI: 0405686902112UV
Reference: 10446535
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:13

Manufacturer products View details

Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter II

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047988984
Basic UDI-DI: 0810047980013AGG
Reference: ACA403r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230666

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230666
Basic UDI-DI: 697733823000GDQ
Reference: C61-GKUC200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Portable Reader

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842857
Basic UDI-DI: 0810047980015AGN
Reference: ACA101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230482

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230482
Basic UDI-DI: 697733823000HDS
Reference: L21-LR300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842895
Basic UDI-DI: 0810047980016AGR
Reference: ACA406r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230680

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230680
Basic UDI-DI: 697733823000KDY
Reference: C61-UAA100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoasasy Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510280
Basic UDI-DI: 0810164510000MZ
Reference: EQB01-FI
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoasasy Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510297
Basic UDI-DI: 0810164510000MZ
Reference: EQD01-FI
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoasasy Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164511218
Basic UDI-DI: 0810164510000MZ
Reference: EQE01-FI
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoasasy Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510587
Basic UDI-DI: 0810164510000MZ
Reference: EQC01-FI
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:12

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose/Ketone/Uric Acid/Total Cholesterol Meter

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510372
Basic UDI-DI: 0810164510005NB
Reference: EKA01-GKUC
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-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: 08033803510423
Basic UDI-DI: 803380351BCAAMIURAONE014X
Reference: I3310001209
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:08

Manufacturer products View details

Glucose/Ketone/Uric Acid/Total Cholesterol Meter Pro

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510433
Basic UDI-DI: 0810164510006ND
Reference: EKB01-GKUC
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Meter

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510419
Basic UDI-DI: 0810164510013NA
Reference: EKA01-UAR
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

Reader-1-S

IVD generalIVDDNo longer on the marketInstrumentProfessional testing

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823READER1SLN
Basic UDI-DI: B-FIMF16823READER1SLN
Reference: Reader-1-S
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:33

Manufacturer products View details

NS Biotec electrolyte analyzer

EA-205

IVD generalIVDDNo longer on the marketInstrumentKit

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-EG-MF-000032515KP
Basic UDI-DI: B-EG-MF-000032515KP
Reference: EA205
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-EC9404001B9

Glycated Hemoglobin Analyzer Column S

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EC9404001B9
Basic UDI-DI: B-EC9404001B9
Reference: EC9404001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details