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01.08.2026 13:11

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19 device results listed.

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IHBSG-C31

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHBSG-C31AR
Basic UDI-DI: B-IHBSG-C31AR
Reference: IHBSG-C31
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

HBsAg Test Pro

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187966
Basic UDI-DI: B-08693285187966
Reference: TIHB04340
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

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HBsAg Test Single

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187904
Basic UDI-DI: B-08693285187904
Reference: TIHB04205
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

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HBsAg Test Single

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187881
Basic UDI-DI: B-08693285187881
Reference: TIHB04220
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

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HBsAg Test Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187874
Basic UDI-DI: B-08693285187874
Reference: TIHB04140
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

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HBsAg Test Eco

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285186693
Basic UDI-DI: B-08693285186693
Reference: TIHB04
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

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HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285186686
Basic UDI-DI: B-08693285186686
Reference: TIHB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182763
Basic UDI-DI: B-08693285182763
Reference: IHB04
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182688
Basic UDI-DI: B-08693285182688
Reference: RTHB04
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285182602
Basic UDI-DI: B-08693285182602
Reference: THB04
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181278
Basic UDI-DI: B-08693285181278
Reference: IHB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181155
Basic UDI-DI: B-08693285181155
Reference: RTHB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181032
Basic UDI-DI: B-08693285181032
Reference: THB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

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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