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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Level 1: 1x0.2 mL (low value); Level 2: 1x0.2 mL (high value)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071267
Basic UDI-DI: B-06978139071267
Reference: 0320301151
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

Quanlity Control For Urine Analyzer

BQ-B U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752361
Basic UDI-DI: B-06976374752361
Reference: BQ-B U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR089）
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:44

Manufacturer products Authorised representative products Authorised representative actors View details

Quanlity Control For Urine Analyzer

BQ-A U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374752354
Basic UDI-DI: B-06976374752354
Reference: BQ-A U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR088）
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 07.07.2026 00:44

Manufacturer products Authorised representative products Authorised representative actors View details

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519631448
Basic UDI-DI: B-06975519631448
Reference: LA-137-2
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519631431
Basic UDI-DI: B-06975519631431
Reference: LA-137-1
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630656
Basic UDI-DI: B-06975519630656
Reference: LA-133-1
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Multiple Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Xilaiheng Medical Electronics Co.,Ltd.
Manufacturer SRN: CN-MF-000047090
UDI-DI: 06975200381157
Basic UDI-DI: B-06975200381157
Reference: Q301
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analyzer Quality Control Set

UP-QC-Ⅳ

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362358
Basic UDI-DI: B-06974735362358
Reference: UP-QC-Ⅳ
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analyzer Quality Control Set

UP-QC-Ⅲ

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362341
Basic UDI-DI: B-06974735362341
Reference: UP-QC-Ⅲ
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analyzer Quality Control Set

UP-QC-Ⅱ

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362334
Basic UDI-DI: B-06974735362334
Reference: UP-QC-Ⅱ
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analyzer Quality Control Set

UP-QC-Ⅰ

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362327
Basic UDI-DI: B-06974735362327
Reference: UP-QC-Ⅰ
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analysis Specific Gravity Quality Control

SG-QC-Ⅰ

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361535
Basic UDI-DI: B-06974735361535
Reference: SG-QC-Ⅰ
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

QC-5 , QCP-5, QC-TCO2

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337850150
Basic UDI-DI: B-06972337850150
Reference: QC-5 low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Diagnosis Quality Control Kit

Vaginitis Diagnosis Quality Control Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235844947
Basic UDI-DI: B-06972235844947
Reference: LTA120101
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solutions

GCS-L2

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

Manufacturer: YASEE BioMedical Inc.
Manufacturer SRN: CN-MF-000037011
UDI-DI: 06971969566125
Basic UDI-DI: B-06971969566125
Reference: GCS-L2
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Prolinx GmbH
Last updated: 06.07.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solutions

GCS-L1

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

Manufacturer: YASEE BioMedical Inc.
Manufacturer SRN: CN-MF-000037011
UDI-DI: 06971969566118
Basic UDI-DI: B-06971969566118
Reference: GCS-L1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Prolinx GmbH
Last updated: 06.07.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

A1c Go HbA1c Control

A1c Go HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937966
Basic UDI-DI: B-06971225937966
Reference: HBDMAC2
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

A1c Go HbA1c Control

A1c Go HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225937959
Basic UDI-DI: B-06971225937959
Reference: HBDMAC1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control High Level

HbA1c Control High Level

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930547
Basic UDI-DI: B-06971225930547
Reference: HBDM072H
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930301
Basic UDI-DI: B-06971225930301
Reference: HBDM072
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details