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

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HbA1c Control Material

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062044
Basic UDI-DI: 6970341680320200101JD
Reference: 0320200301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984061986
Basic UDI-DI: 6970341680320200102JF
Reference: 0320200201
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Meter 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: 06936983165068
Basic UDI-DI: 6970277510019SZF
Reference: AGL-400
EMDN: W01010213
EMDN description: GLUCOSE
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

FOB Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104401
Basic UDI-DI: 6970277510000BXD
Reference: TFO-N601
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer Solution

5×TBE

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304663
Basic UDI-DI: 695593130024040001JQ
Reference: 240401
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer Solution

20×SSC

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304618
Basic UDI-DI: 695593130024030001JD
Reference: 240301
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer Solution

10%SDS

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304557
Basic UDI-DI: 695593130024020001J2
Reference: 240201
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer Solution

1M Sodium Citrate

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304489
Basic UDI-DI: 695593130024011903KF
Reference: 2401SC
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

MR Serum Standard

105-001689-00、105-001690-00、105-001691-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026497
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001689-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

Chloride electrode

040-000542-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024646
Basic UDI-DI: 69449040SHYQ-200BCl****YL
Reference: 040-000542-00
EMDN: W0101070103
EMDN description: CHLORIDE - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Potassium electrode

040-000541-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024639
Basic UDI-DI: 69449040SHYQ-200BK*****F8
Reference: 040-000541-00
EMDN: W0101070106
EMDN description: POTASSIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Sodium electrode

040-000540-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024622
Basic UDI-DI: 69449040SHYQ-200BNa****ZA
Reference: 040-000540-00
EMDN: W0101070107
EMDN description: SODIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Reference electrode

040-000539-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024615
Basic UDI-DI: 69449040SHYQ-200BREF***YW
Reference: 040-000539-00
EMDN: W0101070199
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Calibrator

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053068581
Basic UDI-DI: 69449040AB760000364
Reference: 105-043513-00
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

MR Buffer solution

105-001688-00、105-001692-00、105-001693-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039895
Basic UDI-DI: 69449040BA80ISESOLUTIONZJ
Reference: 105-036023-00
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sodium electrode

115-084090-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025126
Basic UDI-DI: 69449040SHYQ-200CNa****ZT
Reference: 115-084090-00
EMDN: W0101070107
EMDN description: SODIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Chloride electrode

115-084091-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025119
Basic UDI-DI: 69449040SHYQ-200CCl****Z5
Reference: 115-084091-00
EMDN: W0101070103
EMDN description: CHLORIDE - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Potassium electrode

115-084089-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025102
Basic UDI-DI: 69449040SHYQ-200CK*****FR
Reference: 115-084089-00
EMDN: W0101070106
EMDN description: POTASSIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reference electrode

115-084088-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025096
Basic UDI-DI: 69449040SHYQ-200CREF***ZF
Reference: 115-084088-00
EMDN: W0101070199
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)

105-009264-00、105-002254-00、105-002255-00、105-002308-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032269
Basic UDI-DI: 69449040004JG6PD*******C3
Reference: 105-002254-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details