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Prueba Rápida de HBsAg en Casete

Prueba Rápida de HBsAg en Casete

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551378
Basic UDI-DI: B-08436592551378
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 08.07.2026 00:51

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Hepatitis B Virus Surface Antigen (HBsAg) Test

Cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560874
Basic UDI-DI: B-00628347560874
Reference: A02-01-222
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

IHBsg-402001

IVD Class DIVDR 2017/746Not intended for EU marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999410008
Basic UDI-DI: 69529994HBV0001X4
Reference: IHBsg-402001
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: -
Safety summary (SSCP/SSP): IVDRTF-0010 CH7.4 · Rev. 4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Artron Hepatitis B Surface Antigen (HBsAg) Test

Cassette

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560881
Basic UDI-DI: 62834756AL0201025Z
Reference: A02-01-322P25
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HBsAg-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

IHBsg-402

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999407428
Basic UDI-DI: B-06952999407428
Reference: IHBsg-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex Hepatitis B Surface Antigen (HBsAg) Test

-

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

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560928
Basic UDI-DI: 62834756AL0201025Z
Reference: AM02-01-322P25
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AR-SSP-HBsAg-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.06.2026 16:55

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details