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H. pylori Antigen Rapid Test cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983109611
Basic UDI-DI: B-06936983109611
Reference: IHP-602H
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

HIV 1.2 Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106030
Basic UDI-DI: B-06936983106030
Reference: IHI-402
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106023
Basic UDI-DI: B-06936983106023
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Rapid Test Cassette

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106016
Basic UDI-DI: B-06936983106016
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella typhi Antigen Rapid Test Cassette

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104098
Basic UDI-DI: B-06936983104098
Reference: ISTY-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v./Pan Rapid Test Malaria Test Cassette

Malaria P.f./P.v./Pan Rapid Test Malaria Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100939
Basic UDI-DI: B-06936983100939
Reference: IMPVF-402
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06936791030046

10 Tests/Kit

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791030046
Basic UDI-DI: B-06936791030046
Reference: XG030311
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791030039

1 Test/Kit

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791030039
Basic UDI-DI: B-06936791030039
Reference: XG030311
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791030022

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791030022
Basic UDI-DI: B-06936791030022
Reference: XG030312
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791030015

1 test/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791030015
Basic UDI-DI: B-06936791030015
Reference: XG030312
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020108

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020108
Basic UDI-DI: B-06936791020108
Reference: JL0301-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020092

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020092
Basic UDI-DI: B-06936791020092
Reference: EX0402-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020085

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020085
Basic UDI-DI: B-06936791020085
Reference: EX0401-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020078

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020078
Basic UDI-DI: B-06936791020078
Reference: EX0301-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020047

10 Tests/Kit

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020047
Basic UDI-DI: B-06936791020047
Reference: XG0310-10
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020030

1 Test/Kit

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020030
Basic UDI-DI: B-06936791020030
Reference: XG0310-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020023

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020023
Basic UDI-DI: B-06936791020023
Reference: XG0303001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

06936791020016

1 Test/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791020016
Basic UDI-DI: B-06936791020016
Reference: XG0303001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

06930317808522

20 tests (A)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317808522
Basic UDI-DI: B-06930317808522
Reference: DNK-2104-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801356

20 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801356
Basic UDI-DI: B-06930317801356
Reference: DNK-2104-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details