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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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22.09.2026 15:09

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Active filter:Manufacturer SRN:CN-MF-000019109

313 device results listed.

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Dengue NS1 Rapid Test (Whole Blood/Serum/Plasma)

Dengue NS1 Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN001ESRX
Basic UDI-DI: B-697424646DEN001ESRX
Reference: DEN-4012
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM/NS1 Combo Rapid Test (Whole Blood/Serum/Plasma)

Dengue IgG/IgM/NS1 Combo Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN001EQRT
Basic UDI-DI: B-697424646DEN001EQRT
Reference: DEN-4032/DEN-3032
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma)

Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN000EQRN
Basic UDI-DI: B-697424646DEN000EQRN
Reference: DEN-3022
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Rapid Test Kit(Whole Blood/plasma)

D-Dimer Rapid Test Kit(Whole Blood/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646D-DIM000KVCQ
Basic UDI-DI: B-697424646D-DIM000KVCQ
Reference: DIM-4012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(CTNI) Rapid Test (Serum/Plasma)

Cardiac Troponin I(CTNI) Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI002UCKR
Basic UDI-DI: B-697424646CTNI002UCKR
Reference: CTNI-3012
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I(CTNI) Rapid Test (Whole Blood/Serum/Plasma)

Cardiac Troponin I(CTNI) Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI001UAKG
Basic UDI-DI: B-697424646CTNI001UAKG
Reference: CTNI-4012
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I FIA Test (Serum/Plasma)

Cardiac Troponin I FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI001F6W3G
Basic UDI-DI: B-697424646CTNI001F6W3G
Reference: CTNI-3012F
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)

Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI000U8JT
Basic UDI-DI: B-697424646CTNI000U8JT
Reference: CTNI-4012
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I FIA Test (Whole blood/Serum/Plasma)

Cardiac Troponin I FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI000F6T33
Basic UDI-DI: B-697424646CTNI000F6T33
Reference: CTNI-4012F
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

C-reactive protein FIA Test (Serum/Plasma)

C-reactive protein FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CRP001FQ9C5
Basic UDI-DI: B-697424646CRP001FQ9C5
Reference: CRP-3012F
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

C-reactive protein FIA Test (Whole blood/Serum/Plasma)

C-reactive protein FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CRP000FQ6BQ
Basic UDI-DI: B-697424646CRP000FQ6BQ
Reference: CRP-4012F
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)

COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAB000FL5QW
Basic UDI-DI: B-697424646COVAB000FL5QW
Reference: COV Ab-4012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen FIA Test (Swab)

COVID-19 Antigen FIA Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAG000FMUVL
Basic UDI-DI: B-697424646COVAG000FMUVL
Reference: COV Ag-6012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM FIA Test (Serum/Plasma)

COVID-19 IgG/IgM FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COVAB001FL8RB
Basic UDI-DI: B-697424646COVAB001FL8RB
Reference: COV Ab-3012F
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine(COT) Rapid Test (Urine)

Cotinine(COT) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COT001K5XU
Basic UDI-DI: B-697424646COT001K5XU
Reference: COT-1011/COT-1012/COT-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine(COT) Rapid Test(Saliva)

Cotinine(COT) Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COT002K7Y5
Basic UDI-DI: B-697424646COT002K7Y5
Reference: COT-7011/COT-7012/COT-7014/COT-7015
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine(COT) Rapid Test Kit (Urine)

Cotinine(COT) Rapid Test Kit (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COT000K3XK
Basic UDI-DI: B-697424646COT000K3XK
Reference: COT-1011/COT-1012/COT-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine(COT) Rapid Test Kit(Saliva)

Cotinine(COT) Rapid Test Kit(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COT(S)000K3BW
Basic UDI-DI: B-697424646COT(S)000K3BW
Reference: COT-7012/COT-7014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine(COD) Rapid Test(Urine)

Codeine(COD) Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COD001FMSB
Basic UDI-DI: B-697424646COD001FMSB
Reference: COD-1011/COD-1012/COD-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine(COD) Rapid Test(Saliva)

Codeine(COD) Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646COD002FPSN
Basic UDI-DI: B-697424646COD002FPSN
Reference: COD-7011/COD-7012/COD-7014/COD-7015
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details