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

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22.09.2026 16:13

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329 device results listed.

Page 13 / 17

ICA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813166
Basic UDI-DI: 697388081019P5
Reference: ZCC053
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Diabetes Multi Control

Autoimmune Diabetes Multi Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813159
Basic UDI-DI: 697388081020NN
Reference: ZCC052
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgA Control

β2-Glycoprotein I IgA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813081
Basic UDI-DI: 697388081018P3
Reference: ZCC045
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgA Control

Cardiolipin IgA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813074
Basic UDI-DI: 697388081013NR
Reference: ZCC044
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

dsDNA IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812725
Basic UDI-DI: 697388081003NN
Reference: ZCC008
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812718
Basic UDI-DI: 697388081014NT
Reference: ZCC007
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein I Control

Anti-β2-Glycoprotein I Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812701
Basic UDI-DI: 697388081017NZ
Reference: ZCC006
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgM Control

β2-Glycoprotein I IgM Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812695
Basic UDI-DI: 697388081016NX
Reference: ZCC005
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgG Control

β2-Glycoprotein I IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812688
Basic UDI-DI: 697388081015NV
Reference: ZCC004
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgG Control

Cardiolipin IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812657
Basic UDI-DI: 697388081011NM
Reference: ZCC001
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin Control

Anti-Cardiolipin Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812671
Basic UDI-DI: 697388081010NK
Reference: ZCC003
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgM Control

Cardiolipin IgM Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812664
Basic UDI-DI: 697388081012NP
Reference: ZCC002
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-β2-Glycoprotein 1 (CLIA) Controls

Anti-β2-Glycoprotein 1 (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145583910
Basic UDI-DI: 69471455442WB
Reference: 160201442MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Cardiolipin (CLIA) Controls

Anti-Cardiolipin (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145583873
Basic UDI-DI: 69471455438WL
Reference: 160201438MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-Cardiolipin IgA (CLIA) Controls

Anti-Cardiolipin IgA (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145583835
Basic UDI-DI: 69471455435WE
Reference: 160201435MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-β2-Glycoprotein 1 IgA (CLIA) Controls

Anti-β2-Glycoprotein 1 IgA (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145575434
Basic UDI-DI: 69471455439WN
Reference: 160201439MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-DGP IgG (CLIA) Controls

Anti-DGP IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145565039
Basic UDI-DI: 69471455446WK
Reference: 160201446MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-tissue Transglutaminase IgA (CLIA) Controls

Anti-tissue Transglutaminase IgA (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145564919
Basic UDI-DI: 69471455443WD
Reference: 160201443MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-DGP IgA (CLIA) Controls

Anti-DGP IgA (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145564995
Basic UDI-DI: 69471455445WH
Reference: 160201445MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-tissue Transglutaminase IgG (CLIA) Controls

Anti-tissue Transglutaminase IgG (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145564957
Basic UDI-DI: 69471455444WF
Reference: 160201444MT
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details