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922 device results listed.

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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

ACCUGENCE®

PM800

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: e-LinkCare Meditech Co.,Ltd.
Manufacturer SRN: CN-MF-000019475
UDI-DI: 06971404131369
Basic UDI-DI: B-06971404131369
Reference: PM8002011
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

ACCUGENCE®

PM910

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: e-LinkCare Meditech Co.,Ltd.
Manufacturer SRN: CN-MF-000019475
UDI-DI: 06971404130904
Basic UDI-DI: B-06971404130904
Reference: PM9102014
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 12:56

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

D-069396639887044S

CDS-101

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagent

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: D-069396639887044S
Basic UDI-DI: B-069396639887044S
Reference: CDS-101
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:24

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

Manufacturer products View details

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

Dcont ETALON

IVD Class CNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782225
Basic UDI-DI: 59973457DEK7V
Reference: D71-800100
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Dcont NOVUM

IVD Class CNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782263
Basic UDI-DI: 59973457DEK7V
Reference: D72-800300
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Dcont ETALON B

IVD Class CNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782270
Basic UDI-DI: 59973457DEK7V
Reference: D73-800200
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Dcont NOVUM Kit

Class IIaNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-PR-000004110
UDI-DI: 05997345782850
Basic UDI-DI: 59973457DEV8K
Reference: D72-9903
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Dcont ETALON B Kit

Class IIaNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-PR-000004110
UDI-DI: 05997345782867
Basic UDI-DI: 59973457DEV8K
Reference: D73-9901
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Dcont ROLL Kit

Class IIaNot specifiedOn the market

Manufacturer: 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-PR-000004110
UDI-DI: 05997345782874
Basic UDI-DI: 59973457DEV8K
Reference: D75-9901
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 08:58

Manufacturer products View details

Agamatrix Wavesense Jazz Wireless meter

8000-10409

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: AgaMatrix, Inc.
Manufacturer SRN: US-MF-000039145
UDI-DI: 05060181540028
Basic UDI-DI: B-05060181540028
Reference: 8000-10409
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: MDSS GmbH
Last updated: 06.07.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag Self Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681796
Basic UDI-DI: B-04713945681796
Reference: 681.79
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Monitoring System for self-testing

D48531

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180024
Basic UDI-DI: B-04260423180024
Reference: D48531
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Monitoring System for self-testing (mmol)

21514

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110332
Basic UDI-DI: B-04260235110332
Reference: 21514
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Monitoring System for self-testing (mg)

21499

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110141
Basic UDI-DI: B-04260235110141
Reference: 21499
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Monitoring System for self-testing

INFS003KG

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260072576513
Basic UDI-DI: B-04260072576513
Reference: INFS003KG
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details