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350 device results listed.

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Dry Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Astrabio Technology Co., Ltd.
Manufacturer SRN: CN-MF-000041763
UDI-DI: 06977100860190
Basic UDI-DI: 697710086ASTDFL8
Reference: 8900018200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460020

BF-300

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460020
Basic UDI-DI: B-06935784460020
Reference: BF-M11
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: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784460013

BF-100

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784460013
Basic UDI-DI: B-06935784460013
Reference: BF-M31
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: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061027264436
Basic UDI-DI: 5060599401942YP
Reference: RL-CHOM-1AS
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

NIOX

NIOX Sensor

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030274
Basic UDI-DI: 735004703NIOXSENSORG2
Reference: 12-1630
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Sweden
Authorised representative: -
Last updated: 17.07.2026 05:35

Manufacturer products View details

D-CNMF000014455-BF-M347S

BF-130

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-M347S
Basic UDI-DI: B-CNMF000014455-BF-M347S
Reference: BF-M34
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 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M337Q

BF-120

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-M337Q
Basic UDI-DI: B-CNMF000014455-BF-M337Q
Reference: BF-M33
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 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M327N

BF-110

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-M327N
Basic UDI-DI: B-CNMF000014455-BF-M327N
Reference: BF-M32
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 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-M227K

BF-331

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-M227K
Basic UDI-DI: B-CNMF000014455-BF-M227K
Reference: BF-M22
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-M217H

BF-330

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-M217H
Basic UDI-DI: B-CNMF000014455-BF-M217H
Reference: BF-330
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-M147L

BF-031

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-M147L
Basic UDI-DI: B-CNMF000014455-BF-M147L
Reference: BF-M14
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-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

06971771201047

BHS-101

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201047
Basic UDI-DI: B-06971771201047
Reference: BHS-101
EMDN: W0201069092
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
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

NIOX

NIOX Sensor

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030267
Basic UDI-DI: 735004703NIOXSENSORG2
Reference: 12-1610
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

NIOX

NIOX Breathing Handle

IVD Class BIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testing

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030175
Basic UDI-DI: 735004703NIOXHANDLE6R
Reference: 12-1010
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
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