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Mycoplasma Pneumoniae Antigen Rapid Test Device

A46710120,A46710220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804832063
Basic UDI-DI: 69528048A4671002Q
Reference: A46710
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

STB-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827014
Basic UDI-DI: B-06952804827014
Reference: STB-S23
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

STA-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827007
Basic UDI-DI: B-06952804827007
Reference: STA-S23
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804825638

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825638
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Malta
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibodies Rapid Test

HP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819354
Basic UDI-DI: B-06952804819354
Reference: HP-W23
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test

SYP-P11, SYP-P23, SYP-W11, SYP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817657
Basic UDI-DI: B-06952804817657
Reference: SYP-P11 SYP-P23 SYP-W11 SYP-W23
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibodies Rapid Test

HP-P11, HP-P23, HP-W11, HP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804816681
Basic UDI-DI: B-06952804816681
Reference: HP-P11 HP-P23 HP-W11 HP-W23
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811174
Basic UDI-DI: B-06952804811174
Reference: SPN-U23
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Antigen Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811167
Basic UDI-DI: B-06952804811167
Reference: LEG-U23
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810672
Basic UDI-DI: B-06952804810672
Reference: TB-W23
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809720
Basic UDI-DI: 69528048A463101ZT
Reference: A46310120
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody FIA

HP-W23F3

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803841
Basic UDI-DI: B-06952804803841
Reference: HP-W23F3
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis FIA

SYP-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803834
Basic UDI-DI: B-06952804803834
Reference: SYP-W23F3
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile GDH FIA

GDH-F23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803827
Basic UDI-DI: B-06952804803827
Reference: GDH-F23F3
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen FIA

HP-F23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803780
Basic UDI-DI: B-06952804803780
Reference: HP-F23F3
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

06952804803612

Cryptococcus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803612
Basic UDI-DI: B-06952804803612
Reference: /
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

06952804803605

Giardia lamblia Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803605
Basic UDI-DI: B-06952804803605
Reference: GL-F23
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

STA FIA

STA-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802899
Basic UDI-DI: B-06952804802899
Reference: STA-S23F3
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996053938
Basic UDI-DI: B-06950996053938
Reference: GCSTR-502a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996025713
Basic UDI-DI: B-06950996025713
Reference: GCSTR-501a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details