UTSBridge

Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

22.09.2026 11:56

Sync status

Successful

Device

3537119

Actor

47728

Certificate

3381

Active filter:EMDN:W0105090201

26 device results listed.

Page 1 / 2

CSVXML
CupiKIT

Hepatitis B Surface Antigen (HBsAg) Test Kit

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use
Manufacturer
Cupid Limited
Manufacturer SRN
IN-MF-000033199
UDI-DI
08906005286024
Basic UDI-DI
890600528cuphbsL5
Reference
CUPHBS-01
EMDN
W0105090201
EMDN description
HBSAG - RT & POC
First on market country
Austria
Safety summary (SSCP/SSP)
QA/093/F-03 · Rev. 01
Authorised representative
Amstermed B.V.
Last updated
04.08.2026 22:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
MP Diagnostics HBsAg ELISA 4.1

23470-480 (480 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing
Manufacturer
MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN
SG-MF-000024819
UDI-DI
08887581001006
Basic UDI-DI
B-08887581001006
Reference
23470-480
EMDN
W0105090201
EMDN description
HBSAG - RT & POC
First on market country
Germany
Authorised representative
MP Biomedicals Germany GmbH
Last updated
04.08.2026 14:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MP Diagnostics HBsAg ELISA 4.1

23470-096 (96 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing
Manufacturer
MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN
SG-MF-000024819
UDI-DI
08887581000610
Basic UDI-DI
B-08887581000610
Reference
23470-096
EMDN
W0105090201
EMDN description
HBSAG - RT & POC
First on market country
Germany
Authorised representative
MP Biomedicals Germany GmbH
Last updated
04.08.2026 14:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HBsAg Rapid Test Cassette

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
06936983122986
Basic UDI-DI
B-06936983122986
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 14:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HBsAg Rapid Test Cassette

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
06936983122955
Basic UDI-DI
B-06936983122955
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 productsAuthorised representative productsAuthorised representative actorsView details
HBsAg Rapid Test Cassette

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 productsAuthorised representative productsAuthorised representative actorsView details
HBsAg Rapid Test Cassette

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 productsAuthorised representative productsAuthorised representative actorsView details
RightSign

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 productsAuthorised representative productsAuthorised representative actorsView details
08693285187966

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
Manufacturer productsView details
08693285187904

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
Manufacturer productsView details
08693285187881

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
Manufacturer productsView details
08693285187874

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
Manufacturer productsView details
08693285186693

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
Manufacturer productsView details
08693285186686

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 productsView details
08693285182763

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 productsView details
08693285182688

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 productsView details
08693285182602

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 productsView details
08693285181278

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 productsView details
08693285181155

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 productsView details
08693285181032

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
Manufacturer productsView details