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873 device results listed.

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06971771204109

TCM-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771204109
Basic UDI-DI: 697177120TCM101GN
Reference: TCM-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 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

06971771202907

GUC-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771202907
Basic UDI-DI: 697177120GUC101FD
Reference: GUC-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 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

06971771202655

GUK-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771202655
Basic UDI-DI: 697177120GUK101H5
Reference: GUK-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 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

RFM-201

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200514
Basic UDI-DI: 697177120RFM201H2
Reference: RFM-201
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 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood glucose meter

KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571583
Basic UDI-DI: 69507155KBGMT5
Reference: KF-B12
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567845
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B06
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

blood glucose meter

CGH09，CGH10，CGH11，CGH25，CGH30

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715563175
Basic UDI-DI: 69507155CBGMRD
Reference: CGH11
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

SPINCHIP Analyzer

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026645311
Basic UDI-DI: 357302BUDI002310TA
Reference: 425326
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

OraFusion Software

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

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00850050841005
Basic UDI-DI: 086000093094000005S5
Reference: 4000005
EMDN: W0201069082
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 16.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-channel Immunofluorescence Analyzer

OG-G260C

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

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346598
Basic UDI-DI: 0850076346OG-G260C6J
Reference: OG-G260C
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: 16.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567869
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B06
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567883
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567906
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567920
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B12
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571811
Basic UDI-DI: 69507155KKIT4S9
Reference: KF-B12
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

Glucose/Ketone/Uric Acid/Total Cholesterol Meter Pro

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510426
Basic UDI-DI: 0810164510006ND
Reference: EQB01-GKUC
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 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Meter

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510402
Basic UDI-DI: 0810164510013NA
Reference: EQA01-UAR
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 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose/Ketone/Uric Acid/Total Cholesterol Meter

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510365
Basic UDI-DI: 0810164510005NB
Reference: EQA01-GKUC
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 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842888
Basic UDI-DI: 0810047980016AGR
Reference: ACA406
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047989066
Basic UDI-DI: 0810047980011AGA
Reference: ACA401
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details