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

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Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Leishmaniasis IgG/IgM 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-697424646LEI001GXV6
Basic UDI-DI: B-697424646LEI001GXV6
Reference: LEI-4021/LEI-4022
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmaniasis Rapid Test (Whole Blood/serum/plasma)

Leishmaniasis 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-697424646LEI000GVUV
Basic UDI-DI: B-697424646LEI000GVUV
Reference: LEI-4011/LEI-4012
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus Rapid Test(WB/S/P)

Hantavirus Rapid Test(WB/S/P)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HV001H4K2
Basic UDI-DI: B-697424646HV001H4K2
Reference: HV-4012
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus IgG/IgM Rapid Test(WB/S/P)

Hantavirus IgG/IgM Rapid Test(WB/S/P)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HV000H2JR
Basic UDI-DI: B-697424646HV000H2JR
Reference: HV-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes simplex virus(HSV) IgG/IgM Rapid Test (Serum/Plasma)

Herpes simplex virus(HSV) IgG/IgM 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-697424646HSV002P26A
Basic UDI-DI: B-697424646HSV002P26A
Reference: HSV-3022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes simplex virus(HSV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Herpes simplex virus(HSV) IgG/IgM 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-697424646HSV001NY8B
Basic UDI-DI: B-697424646HSV001NY8B
Reference: HSV-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma)

Herpes simplex virus 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-697424646HSV000NW82
Basic UDI-DI: B-697424646HSV000NW82
Reference: HSV-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test (Feces)

H.pylori Antigen Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAG001QECU
Basic UDI-DI: B-697424646HPAG001QECU
Reference: HPAg-5011/HPAg-5012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen FIA Test (Feces)

H.pylori Antigen FIA Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HPAG000FZLWM
Basic UDI-DI: B-697424646HPAG000FZLWM
Reference: HPAg -5012F
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibodies Rapid Test (Whole Blood/Serum/Plasma)

H.pylori Antibodies 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-697424646HPAB001PBAJ
Basic UDI-DI: B-697424646HPAB001PBAJ
Reference: HPAb-4011/HPAb-4012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibodies Rapid Test (Serum/Plasma)

H.pylori Antibodies 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-697424646HPAB002PDAT
Basic UDI-DI: B-697424646HPAB002PDAT
Reference: HPAb-3011/HPAb-3012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)"

"H.pylori Antibodies 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-697424646HP000FQHZ
Basic UDI-DI: B-697424646HP000FQHZ
Reference: HPAb-4011/HPAb-4012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test Kit(Feces)

H.pylori Antigen Rapid Test Kit(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HP(F)000FQ86
Basic UDI-DI: B-697424646HP(F)000FQ86
Reference: HPAg-5011/HPAg-5012
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Serum/Plasma)

Hepatitis A Virus(HAV) IgG/IgM 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-697424646HAV004GYWG
Basic UDI-DI: B-697424646HAV004GYWG
Reference: HAV-3022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma)

Hepatitis A Virus(HAV) IgM 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-697424646HAV003GWW7
Basic UDI-DI: B-697424646HAV003GWW7
Reference: HAV-3012
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Hepatitis A Virus(HAV) IgG/IgM 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-697424646HAV002GUVW
Basic UDI-DI: B-697424646HAV002GUVW
Reference: HAV-4022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma)

Hepatitis A Virus(HAV) IgM 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-697424646HAV001GSVM
Basic UDI-DI: B-697424646HAV001GSVM
Reference: HAV-4012
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma)

Hepatitis A Virus 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-697424646HAV000GQVC
Basic UDI-DI: B-697424646HAV000GQVC
Reference: HAV-4012/HAV-4022/HAV-3012/HAV-3022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhoea Rapid Test(Swab)

Gonorrhoea Rapid Test(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646GON001KFYS
Basic UDI-DI: B-697424646GON001KFYS
Reference: GON-6012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhoea Rapid Test Kit(Swab)

Gonorrhoea Rapid Test Kit(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646GON000KDYH
Basic UDI-DI: B-697424646GON000KDYH
Reference: GON-6012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details