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IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497880
Basic UDI-DI: 6921756499990047XF
Reference: G135-11H-202
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Safety summary (SSCP/SSP): SSP-0068A/B · Rev. 1.1
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:28

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

06975668510021

Blood glucose Test Strips

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Jinzhun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000027592
UDI-DI: 06975668510021
Basic UDI-DI: 697566851GLUTEST01HC
Reference: W0101060101
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753777

URIT YC 2ST、UNAMAX SG Calibrator、UNAMAX TURBIDITY Calibrator

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753777
Basic UDI-DI: 69357407IUCS000006QW
Reference: USUC00001097
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753746

URIT YQ 3STC、UNAMAX SG Control、UNAMAX COLOR Control、UNAMAX TURBIDITY Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753746
Basic UDI-DI: 69357407IUCS000005QU
Reference: USUC00001103
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753722

UNAMAX U11 Control、UNAMAX U14 Control

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753722
Basic UDI-DI: 69357407IUCS000015QX
Reference: USUC00001081
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753678

URIT 10G、URIT 11G、URIT 14G、LabUSticks 10G、LabUSticks 11G、LabUSticks 14G

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753678
Basic UDI-DI: 69357407IUCS000012QR
Reference: USUC00001029
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution

Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140075
Basic UDI-DI: B-06958982140075
Reference: S9402
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

Strips

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140051
Basic UDI-DI: B-06958982140051
Reference: G9055
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Belgium
Authorised representative: Wellkang Ltd
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

DOASENSE Control Urines

0003

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: DOASENSE GmbH
Manufacturer SRN: DE-MF-000015367
UDI-DI: 04260552660039
Basic UDI-DI: B-04260552660039
Reference: 0003
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Estonia
Authorised representative: -
Last updated: 05.08.2026 12:27

Manufacturer products View details

NOVADIA nero Kontrolllösung HOCH und NORMAL, 2 x 4 ml

TD-4206

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04260492150737
Basic UDI-DI: B-04260492150737
Reference: NOVADIA nero Kontrolllösung HOCH und NORMAL, 2 x 4 ml
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 12:12

Manufacturer products Authorised representative products Authorised representative actors View details

NOVADIA nero TTR, 50 St

TD-4206

IVD Annex II List BIVDDOn the marketCompanion diagnosticsProfessional testingSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04260492150478
Basic UDI-DI: B-04260492150478
Reference: TD-4206
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 12:12

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA® Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04260325295185
Basic UDI-DI: B-04260325295185
Reference: IS20301KT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA® Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04260325295178
Basic UDI-DI: B-04260325295178
Reference: IS20101KT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA® Blood Glucose Test Strip[DE]

Glucose Test Strip

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04260325290029
Basic UDI-DI: B-04260325290029
Reference: IS30101
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

Gluceofine Pro Kontrolllösung

TD-4908

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04260315240089
Basic UDI-DI: B-04260315240089
Reference: TD-4908
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 11:52

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Monitoring System

Precisa

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236851104
Basic UDI-DI: B-04260236851104
Reference: 3K-01-350034
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 05.08.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Test Strip

Precisa

IVD Annex II List BIVDDNo longer on the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236851081
Basic UDI-DI: B-04260236851081
Reference: 3S-01-350036
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Luana Med. B.V.
Last updated: 05.08.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Test Strip

Precisa

IVD Annex II List BIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236850978
Basic UDI-DI: B-04260236850978
Reference: 3S-01-350035
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 05.08.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Test Strip

Precisa

IVD Annex II List BIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236850961
Basic UDI-DI: B-04260236850961
Reference: 3S-01-350033
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 05.08.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Test Strip

Precisa

IVD Annex II List BIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236850817
Basic UDI-DI: B-04260236850817
Reference: 3S-01-350031
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 05.08.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details