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305 device results listed.

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D-CNMF000014455-BF-M137J

BF-030

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M137J
Basic UDI-DI: B-CNMF000014455-BF-M137J
Reference: BF-M13
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M127G

BF-301

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-M127G
Basic UDI-DI: B-CNMF000014455-BF-M127G
Reference: BF-M12
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

06971771201245

RFS-101（25pcs)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201245
Basic UDI-DI: B-06971771201245
Reference: RFS-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors 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

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

06977338230291

Lipid Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230291
Basic UDI-DI: 697733823000DDJ
Reference: C21-LP100
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

06977338230048

Glucose/Ketone/Uric Acid/Total Cholesterol Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230048
Basic UDI-DI: 697733823000FDN
Reference: C21-GKUC100
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

LYSUN

RFM-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209036
Basic UDI-DI: 697177120RFM101GV
Reference: RFM-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

RFM-201

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200514
Basic UDI-DI: 697177120RFM201H2
Reference: RFM-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SPINCHIP Analyzer

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026645311
Basic UDI-DI: 357302BUDI002310TA
Reference: 425326
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

Multi-channel Immunofluorescence Analyzer

OG-G260C

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

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346598
Basic UDI-DI: 0850076346OG-G260C6J
Reference: OG-G260C
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors 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: 00810164510426
Basic UDI-DI: 0810164510006ND
Reference: EQB01-GKUC
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 03:57

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: 00810164510402
Basic UDI-DI: 0810164510013NA
Reference: EQA01-UAR
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 03:57

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: 00810164510365
Basic UDI-DI: 0810164510005NB
Reference: EQA01-GKUC
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 03:57

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: 00810186842888
Basic UDI-DI: 0810047980016AGR
Reference: ACA406
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047989066
Basic UDI-DI: 0810047980011AGA
Reference: ACA401
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

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: 00810047988991
Basic UDI-DI: 0810047980012AGD
Reference: ACA402
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors 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: 00810047988977
Basic UDI-DI: 0810047980013AGG
Reference: ACA403
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

ProciseDx Analyzer

4390

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

Manufacturer: ProciseDx Inc.
Manufacturer SRN: US-MF-000040747
UDI-DI: 08100322943909
Basic UDI-DI: 081003229PDXA439022SS
Reference: 4390
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details