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873 device results listed.

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ACCU-ANSWER

LBM-01

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: Guilin Royalyze Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000038422
UDI-DI: D-697191378-MMQ8
Basic UDI-DI: B-697191378-MMQ8
Reference: LBM-01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Meter

KF-A06-C

IVD Annex II List BIVDDOn the marketInstrumentKitProfessional testingSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: D-69507155KFA06CHP
Basic UDI-DI: B-69507155KFA06CHP
Reference: KFA106
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sejoy

BG-709g

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: D-69396639H6
Basic UDI-DI: B-69396639H6
Reference: BG-709g
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:51

Manufacturer products Authorised representative products Authorised representative actors View details

ACCU-ANSWER

ZH-G01; ZH-G04

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: Guilin Zhonghui Technology Co., Ltd.
Manufacturer SRN: CN-MF-000038423
UDI-DI: D-693748520-BGMSAS
Basic UDI-DI: B-693748520-BGMSAS
Reference: ZH-G01; ZH-G04
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

myPatientSpace

Class IMDDOn the marketActive device

Manufacturer: myPatientSpace Limited
Manufacturer SRN: IE-MF-000042319
UDI-DI: 53915473600010
Basic UDI-DI: B-53915473600010
Reference: 1
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 17.07.2026 02:40

Manufacturer products View details

06971771201245

RFS-101（25pcs)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201245
Basic UDI-DI: B-06971771201245
Reference: RFS-101
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 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06971771201047

BHS-101

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201047
Basic UDI-DI: B-06971771201047
Reference: BHS-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 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769556

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769556
Basic UDI-DI: B-04712558769556
Reference: 1320087
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

NIOX PRO

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

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030724
Basic UDI-DI: 735004703NIOXPROMZ
Reference: 20-1000
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

NIOX

NIOX Sensor

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030267
Basic UDI-DI: 735004703NIOXSENSORG2
Reference: 12-1610
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

NIOX

NIOX Breathing Handle

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

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030175
Basic UDI-DI: 735004703NIOXHANDLE6R
Reference: 12-1010
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:37

Manufacturer products View details

06977338230673

Uric Acid Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230673
Basic UDI-DI: 697733823000KDY
Reference: C21-UAA100
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 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230659

Glucose/Ketone/Uric Acid/Total Cholesterol Analyzer Pro

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230659
Basic UDI-DI: 697733823000GDQ
Reference: C21-GKUC200
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 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230291

Lipid Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230291
Basic UDI-DI: 697733823000DDJ
Reference: C21-LP100
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 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230048

Glucose/Ketone/Uric Acid/Total Cholesterol Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230048
Basic UDI-DI: 697733823000FDN
Reference: C21-GKUC100
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 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

GULP-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771200194
Basic UDI-DI: 697177120GULP101T5
Reference: GULP-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 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Analyzer(HPLC)

H6, H8, H9, H100, H100Plus, 96TH, A10TH, A10,

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062808
Basic UDI-DI: 6970341680120203GU
Reference: NA
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

GUM-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209319
Basic UDI-DI: 697177120GUM101HK
Reference: GUM-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-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209036
Basic UDI-DI: 697177120RFM101GV
Reference: RFM-101
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

06971771204130

GUC-102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771204130
Basic UDI-DI: 697177120GUC102FF
Reference: GUC-102
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