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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

Rotavirus Antigen Rapid Test(Feces)

Rotavirus 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-697424646ROT002RAAC
Basic UDI-DI: B-697424646ROT002RAAC
Reference: ROT-5011/ROT-5012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
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

Rotavirus Rapid Test (Feces)

Rotavirus Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ROT000R69E
Basic UDI-DI: B-697424646ROT000R69E
Reference: ROT-5011/ROT-5012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia Rapid Test Device (Swab)

Chlamydia Rapid Test Device (Swab)

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840313086
Basic UDI-DI: B-69743840313086
Reference: 3020101
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium Difficile Toxin AB+GDH Rapid Test

Clostridium Difficile Toxin AB+GDH Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312300
Basic UDI-DI: B-69743840312300
Reference: 3024703
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium Difficile Toxin A+B Rapid Test

Clostridium Difficile Toxin A+B Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312232
Basic UDI-DI: B-69743840312232
Reference: 3024701
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Ehrlichia Antibody Rapid Test

Ehrlichia Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310498
Basic UDI-DI: B-69743840310498
Reference: 3023501
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Anaplasmosis Antibody Rapid Test

Anaplasmosis Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310184
Basic UDI-DI: B-69743840310184
Reference: 3023401
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

Strep A Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840307900
Basic UDI-DI: B-69743840307900
Reference: 3021104
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis Antibody Rapid Test

Mycobacterium Tuberculosis Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840307832
Basic UDI-DI: B-69743840307832
Reference: 3021801
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid Antigen Rapid Test

Typhoid Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303872
Basic UDI-DI: B-69743840303872
Reference: 3021401
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

H. pylori Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303704
Basic UDI-DI: B-69743840303704
Reference: 3020501
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody Rapid Test

Treponema Pallidum Antibody Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303636
Basic UDI-DI: B-69743840303636
Reference: 3021206
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details