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305 device results listed.

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NIOX VERO

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030205
Basic UDI-DI: B-07350047030205
Reference: 12-1100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:16

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Dry Chemistry Analyzer

CA-101

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519630953
Basic UDI-DI: B-06975519630953
Reference: CC-101-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Lipid Testing System

LP-102

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519630328
Basic UDI-DI: B-06975519630328
Reference: LC-111-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

Lipid Testing System

LP-101

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519630304
Basic UDI-DI: B-06975519630304
Reference: LC-101-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter

Q-3

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168173
Basic UDI-DI: B-06974703168173
Reference: Q-3
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Renal Function Analysis Meter

RFM-202

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200521
Basic UDI-DI: B-06971771200521
Reference: RFM-202
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598223765
Basic UDI-DI: B-06942598223765
Reference: AFR-900
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

SmartTester

IVD Class ANot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345779812
Basic UDI-DI: 59973457SAUASRTGB
Reference: STR-9902-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

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SmartTester

IVD Class ANot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345781365
Basic UDI-DI: 59973457SAUASRTGB
Reference: STR-9903
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

SmartTester

IVD Class ANot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345781372
Basic UDI-DI: 59973457SAUASRTGB
Reference: STR-9904
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

D-01A0212Y2

SPUG

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0212Y2
Basic UDI-DI: B-01A0212Y2
Reference: 4B001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

GENSPEED R2 Analyzer

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

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770014
Basic UDI-DI: 912013177R2analyzerL7
Reference: GSHW001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 03.07.2026 23:59

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08809408861969

INCLIX F-100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408861969
Basic UDI-DI: 88094088IFF-001K2
Reference: IFFD001E
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

A1Care Analyzer

POCSPAL001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712009902
Basic UDI-DI: 8806712POCSPAL001CB
Reference: POCSPAL001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F2400 Analyzer

F2400

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111700118
Basic UDI-DI: 88001117IPAA01FA03UM
Reference: 10FA24
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F200 Analyzer

F200

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111700057
Basic UDI-DI: 88001117IPAA01FA02UK
Reference: 10FA20
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

AUTODXTM Analyzer

Ep.414

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

Manufacturer: DxGen Corp.
Manufacturer SRN: KR-MF-000030876
UDI-DI: 08800031900063
Basic UDI-DI: 88000319RAMS0JY
Reference: E1M100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Epithod®616 Analyzer

Ep.616

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

Manufacturer: DxGen Corp.
Manufacturer SRN: KR-MF-000030876
UDI-DI: 08800031900025
Basic UDI-DI: 88000319RHRA2KQ
Reference: E0M100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

08800026300083

Exdia TRF Plus

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

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300083
Basic UDI-DI: 88000263PDFC20AY
Reference: PD-FC20
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

TEST KASETİ-1 (62’LİK)

CST06-01

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039380
Basic UDI-DI: 868459503CST06NV
Reference: CST06
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:38

Manufacturer products View details