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Micro Heater Incubator

VMFIA1006

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

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032268
Basic UDI-DI: 868459503MH57
Reference: VMH1001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 23:28

Manufacturer products View details

Mini Immunofluorescence Analyzer

OG-H101

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173654708
Basic UDI-DI: 81649002OG-H10189
Reference: OG-H101
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: 31.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Fluorescent Analyzer

OG-G260

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173653022
Basic UDI-DI: 81017365OG-G2604E
Reference: OG-G260
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: 31.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

06972337851591

G20, G21, G60, G80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337851591
Basic UDI-DI: 697233785GHgbA010ME
Reference: G20
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-function analyzer (blood glucose, uric acid, lipids, blood pressure)

IVD Class ANot specifiedNo longer on the market

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200194
Basic UDI-DI: 69717712001948N
Reference: GULP-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

06936983171526

Uric Acid Meter

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983171526
Basic UDI-DI: 6970277510020LYB
Reference: AUAR-100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164825
Basic UDI-DI: 6970277510019RZD
Reference: AGKUCR-200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164795
Basic UDI-DI: 6970277510019QZB
Reference: AGKUCR-100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Glycohemoglobin Analyzer

H50、H50P

IVD Class CIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904052137
Basic UDI-DI: 69449040AB3000012ZG
Reference: H50
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Meter

G-427B,G-425-2

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184631516
Basic UDI-DI: 6939184630001BD
Reference: G-427B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Malta
Safety summary (SSCP/SSP): IVDR-BL-BGMS-21 · Rev. A4
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Sinocare

H102 Air ，H101

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010684
Basic UDI-DI: 6934175001A0620P3
Reference: 7C001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Analyzer FLI-100

FLI-100

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209064
Basic UDI-DI: 69332602IT01000029T
Reference: BT0106
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Analyzer BIOT-YG-I

BIOT-YG-I

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209088
Basic UDI-DI: 69332602IT01000049X
Reference: BT0104
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

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: 06934175010691
Basic UDI-DI: 6934175001A0620P3
Reference: 7C002
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: 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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details