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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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D-697603130101A0201EG7SK

101A0201EY,101A0201ED

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130101A0201EG7SK
Basic UDI-DI: B-697603130101A0201EG7SK
Reference: 101A0201EY,101A0201ED
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgM/IgG Rapid Test(Serum/Plasma)

Zika IgM/IgG 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-697424646ZIKA001Z9QN
Basic UDI-DI: B-697424646ZIKA001Z9QN
Reference: ZIKA-3022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

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

Zika IgM/IgG 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-697424646ZIKA000Z7QD
Basic UDI-DI: B-697424646ZIKA000Z7QD
Reference: ZIKA-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Rapid Test (Serum/Plasma)

Typhoid 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-697424646TYP004USGX
Basic UDI-DI: B-697424646TYP004USGX
Reference: TYP-3022
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

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

Typhoid 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-697424646TYP003UQGN
Basic UDI-DI: B-697424646TYP003UQGN
Reference: TYP-4022
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:16

Manufacturer products Authorised representative products Authorised representative actors View details

S.Typhi(TYP) Antigen Rapid Test (Feces)

S.Typhi(TYP) 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-697424646TYP002UNGB
Basic UDI-DI: B-697424646TYP002UNGB
Reference: TYP Ag-5012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

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

Typhoid 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-697424646TYP000UJFR
Basic UDI-DI: B-697424646TYP000UJFR
Reference: TYP-4022
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

S.Typhi Antigen Rapid Test (Feces)

S.Typhi 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-697424646TYP(F)000UJVY
Basic UDI-DI: B-697424646TYP(F)000UJVY
Reference: TYP Ag-5012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test (Serum/Plasma)

Tuberculosis 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-697424646TB002GWKG
Basic UDI-DI: B-697424646TB002GWKG
Reference: TB-3011/TB-3012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)

Tuberculosis 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-697424646TB001GUK7
Basic UDI-DI: B-697424646TB001GUK7
Reference: TB-4011/TB-4012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)

Tuberculosis 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-697424646TB000GSJW
Basic UDI-DI: B-697424646TB000GSJW
Reference: TB-4011/TB-4012
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test (Serum/Plasma)

Syphilis 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-697424646SYP002U9EG
Basic UDI-DI: B-697424646SYP002U9EG
Reference: SYP-3011/SYP-4011
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test (Whole Blood/Serum/Plasma)

Syphilis 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-697424646SYP001U7E7
Basic UDI-DI: B-697424646SYP001U7E7
Reference: SYP-4011/SYP-4012
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test Kit(Whole Blood/serum/plasma)

Syphilis 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-697424646SYP000U5DW
Basic UDI-DI: B-697424646SYP000U5DW
Reference: SYP-4011/SYP-3011/SYP-4012/SYP-3012
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test (Swab)

Strep B Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STB001PE67
Basic UDI-DI: B-697424646STB001PE67
Reference: STB-6011/STB-6012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Kit (swab)

Strep B 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-697424646STB000PC5W
Basic UDI-DI: B-697424646STB000PC5W
Reference: STB-6011/STB-6012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test (Swab)

Strep A Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STA001P74Y
Basic UDI-DI: B-697424646STA001P74Y
Reference: STA-6011/STA-6012
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Kit (swab)

Strep A 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-697424646STA000P54P
Basic UDI-DI: B-697424646STA000P54P
Reference: STA-6011/STA-6012
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)

Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646RV001LJS2
Basic UDI-DI: B-697424646RV001LJS2
Reference: RV-3022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma)

Rubella.Virus(RV) IgM/IgG 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-697424646RV000LGRP
Basic UDI-DI: B-697424646RV000LGRP
Reference: RV-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details