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

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Tumor Marker Control

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291106HH
Basic UDI-DI: B-EIM4291106HH
Reference: EIM4291106
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Controlv

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01952118H
Basic UDI-DI: B-ECH01952118H
Reference: ECH0195211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01942118A
Basic UDI-DI: B-ECH01942118A
Reference: ECH0194211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01922117U
Basic UDI-DI: B-ECH01922117U
Reference: ECH0192211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

CK & CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01912117M
Basic UDI-DI: B-ECH01912117M
Reference: ECH0191211
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

Adiponectin Control

Adiponectin Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC858RR
Basic UDI-DI: B-CC858RR
Reference: CC858
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

GBM IgG Control

GBM IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC836RF
Basic UDI-DI: B-CC836RF
Reference: CC836
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

MPO IgG Control

MPO IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC834RB
Basic UDI-DI: B-CC834RB
Reference: CC834
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

PR3 IgG Control

PR3 IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC835RD
Basic UDI-DI: B-CC835RD
Reference: CC835
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

dsDNA IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC831R5
Basic UDI-DI: B-CC831R5
Reference: CC831
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC830R3
Basic UDI-DI: B-CC830R3
Reference: CC830
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgA Control

β2-Glycoprotein I IgA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC828RG
Basic UDI-DI: B-CC828RG
Reference: CC828
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgA Control

Cardiolipin IgA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC827RE
Basic UDI-DI: B-CC827RE
Reference: CC827
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-Glycoprotein Ⅰ Control

Anti-β2-Glycoprotein Ⅰ Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC826RC
Basic UDI-DI: B-CC826RC
Reference: CC826
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgM Control

β2-Glycoprotein I IgM Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC825RA
Basic UDI-DI: B-CC825RA
Reference: CC825
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Glycoprotein I IgG Control

β2-Glycoprotein I IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC824R8
Basic UDI-DI: B-CC824R8
Reference: CC824
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cardiolipin Control

Anti-Cardiolipin Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC823R6
Basic UDI-DI: B-CC823R6
Reference: CC823
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgM Control

Cardiolipin IgM Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC822R4
Basic UDI-DI: B-CC822R4
Reference: CC822
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiolipin IgG Control

Cardiolipin IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC821R2
Basic UDI-DI: B-CC821R2
Reference: CC821
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inhibin B Control

Inhibin B Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC819RF
Basic UDI-DI: B-CC819RF
Reference: CC819
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details