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EUDAMED Device Search

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

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370 device results listed.

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Biossays Kappa Light Chain (Immunoturbidimetric)

Kappa Light Chain (Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551087
Basic UDI-DI: 69471455568X2
Reference: 130508016S
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Zinc (PAPS)

Zinc (PAPS)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548995
Basic UDI-DI: 69471455565WU
Reference: 130509006S
EMDN: W01010233
EMDN description: ZINC
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Mitochondrial Aspartate Aminotransferase (Immune Inhibition)

Mitochondrial Aspartate Aminotransferase (Immune Inhibition)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548704
Basic UDI-DI: 69471455566WW
Reference: 130502025S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Monoamine oxidase (Glutamate dehydrogenase)

Monoamine oxidase (Glutamate dehydrogenase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145546489
Basic UDI-DI: 69471455624WK
Reference: 130502024S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Direct Bilirubin Calibrator

Direct Bilirubin (Diazo with Dichloroaniline)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145545956
Basic UDI-DI: 69471455597X9
Reference: 160202597C
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Cholyglycine (Latex Immunoturbidimetric）

Cholyglycine (Latex Immunoturbidimetric）

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145545949
Basic UDI-DI: 69471455603WB
Reference: 130502023S
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI sST2 (CLIA)

sST2 (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145541552
Basic UDI-DI: 69471455186WG
Reference: 130606022M
EMDN: W01021314
EMDN description: ST2
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ammonia (Glutamate dehydrogenase)

Ammonia (Glutamate dehydrogenase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145511180
Basic UDI-DI: 69471455541WE
Reference: 130502010S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Angiotensin I (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580636
Basic UDI-DI: 694714551037J3
Reference: 1302563005M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-ZnT8 (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555429
Basic UDI-DI: 694714551085JE
Reference: 130255008M
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI sST2 (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145541569
Basic UDI-DI: 69471455186WG
Reference: 130206022M
EMDN: W01021314
EMDN description: ST2
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Direct Bilirubin (Diazo with Dichloroaniline)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145571924
Basic UDI-DI: 69471455597X9
Reference: 130502016S
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ischemia Modified Albumin (ACB)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145572464
Basic UDI-DI: 69471455599XD
Reference: 130504007S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Angiotensin Converting Enzyme (FAPGG Substrate)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145572730
Basic UDI-DI: 69471455601W7
Reference: 130504008S
EMDN: W01010109
EMDN description: ANGIOTENSIN CONVERTING ENZYME (CC)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ferritin (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145573546
Basic UDI-DI: 69471455605WF
Reference: 130510001S
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Myoglobin (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145573812
Basic UDI-DI: 69471455606WH
Reference: 130504010S
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI sST2 (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145541583
Basic UDI-DI: 69471455186WG
Reference: 160201186MT
EMDN: W01021314
EMDN description: ST2
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-ZnT8 (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555405
Basic UDI-DI: 694714551085JE
Reference: 130655008M
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Angiotensin I (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580643
Basic UDI-DI: 694714551037J3
Reference: 1602011037MT
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ammonia (Glutamate dehydrogenase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145511227
Basic UDI-DI: 69471455541WE
Reference: 130502010A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details