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873 device results listed.

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Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010707
Basic UDI-DI: 6934175001A0620P3
Reference: 7C003
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010714
Basic UDI-DI: 6934175001A0620P3
Reference: 7C004
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026067
Basic UDI-DI: 6934175001A0620P3
Reference: 7D001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

06925912711063

UNICELL-S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711063
Basic UDI-DI: 692591270143H8
Reference: F6101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

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06925912711056

I-UNICELL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711056
Basic UDI-DI: 692591270146HE
Reference: I6101
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Cyprus
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

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Colloidal Gold Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722973
Basic UDI-DI: 692196372294JJ
Reference: CG-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

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Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963719669
Basic UDI-DI: 692196371965K7
Reference: QDS-300A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

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On Call

OGM-361

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497736
Basic UDI-DI: 6921756499990073XG
Reference: GN112-111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:10

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Labmaster LUCIA™ Analyzer

LM26

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

Manufacturer: Labmaster Oy
Manufacturer SRN: FI-MF-000023942
UDI-DI: 06429810777003
Basic UDI-DI: 6429810777LM268N
Reference: LM26
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:45

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QC Cassette

IVD Class AIVDR 2017/746On the market

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587350004
Basic UDI-DI: 6419587QC0010PV
Reference: 740470
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

GP Reader NT

HIT-92A

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

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587343006
Basic UDI-DI: 6419587RNT0103T
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

Dcont ETALON Kit

Blood glucose meter kit - Dcont ETALON family

Class IIaMDR 2017/745On the market

Manufacturer: 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-PR-000004110
UDI-DI: 05997345782843
Basic UDI-DI: 59973457DEV8K
Reference: D71-9901
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Dcont ROLL

Dcont ETALON

IVD Class CIVDR 2017/746On the marketInstrumentSelf testing

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782171
Basic UDI-DI: 59973457DEK7V
Reference: D75-800100
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Safety summary (SSCP/SSP): SSP Dcont ETALON (D71) and variants, ETALON Teszt test strip v2 · Rev. 6
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products Open in EUDAMED View details

SmartTester

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

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345779775
Basic UDI-DI: 59973457SAUASRTGB
Reference: STR-9901-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Line Portal

Class IMDR 2017/745On the marketActive device

Manufacturer: Line Systems ApS
Manufacturer SRN: DK-MF-000031441
UDI-DI: 05745000980253
Basic UDI-DI: 5745000980LINESYSTEMS013H
Reference: v1.18.x
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:41

Manufacturer products View details

BGI

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

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468324
Basic UDI-DI: 5745000468EU02000200018Q
Reference: EU0200020001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

BGI

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

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468317
Basic UDI-DI: 5745000468EU02000100018D
Reference: EU0200010001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

TruGlyc

TG100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763785
Basic UDI-DI: 5065023763TG100S4
Reference: TG10001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061027264412
Basic UDI-DI: 5060599401942YP
Reference: RL-CHOM-1A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

04987848012005

Bilirubinmeter

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

Manufacturer: APEL Co.,LTD.JAPAN
Manufacturer SRN: JP-MF-000023982
UDI-DI: 04987848012005
Basic UDI-DI: 4987848Bilirubin_AV3
Reference: CAT-1004-3.2
EMDN: W0201069004
EMDN description: BILIRUBINOMETERS
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details