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08693285181971

H.Pylori Ag Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181971
Basic UDI-DI: B-08693285181971
Reference: THP03
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

08693285181964

H.Pylori Ab Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181964
Basic UDI-DI: B-08693285181964
Reference: RTHP02
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:27

Manufacturer products View details

08693285181865

Strep A Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181865
Basic UDI-DI: B-08693285181865
Reference: RTSA01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

08693285181858

H.Pylori Ag Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181858
Basic UDI-DI: B-08693285181858
Reference: RTHP03
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

08693285181315

Anti-Syphilis Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181315
Basic UDI-DI: B-08693285181315
Reference: ITP01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

08693285181193

Anti-Syphilis Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181193
Basic UDI-DI: B-08693285181193
Reference: RTTP01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

08693285181070

Anti-Syphilis Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181070
Basic UDI-DI: B-08693285181070
Reference: TTP01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

WellFor Strep A v2.0 Test Kit

VMD150ST01

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039885
Basic UDI-DI: B-08684595039885
Reference: VMD150ST
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:19

Manufacturer products View details

RapidFor™ H.pylori Ag Rapid Test Kit (FIA)

VMPO67

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030073
Basic UDI-DI: B-08684595030073
Reference: VMPO67
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:12

Manufacturer products View details

RapidFor™ H.Pylori Ag Rapid Test Kit

VMD16

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941230
Basic UDI-DI: B-08683347941230
Reference: VMD16
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

CerTest H. pylori

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440201496
Basic UDI-DI: 84354402IDXGASTROB_P4P
Reference: P820001VC
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 06:46

Manufacturer products View details

CerTest H. pylori

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207603
Basic UDI-DI: 84354402IDXGASTROB_P4P
Reference: P820001VCC
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 06:46

Manufacturer products View details

Campylobacter Prueba Rápida de Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551743
Basic UDI-DI: B-08436592551743
Reference: ICAM-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
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

"Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete "

Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551019
Basic UDI-DI: B-08436592551019
Reference: ICD-635B
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - 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

Casete de Prueba Rápida de Legionella pneumophila

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592550937
Basic UDI-DI: B-08436592550937
Reference: ILEG-102
EMDN: W0105090108
EMDN description: LEGIONELLA - 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

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983139564
Basic UDI-DI: 6970277510014PYS
Reference: ISTB-N502H-01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:49

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

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983177993
Basic UDI-DI: 6970277510014PYS
Reference: ISTB-N502H-01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178006
Basic UDI-DI: 6970277510014PYS
Reference: ISTB-N502H-05
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178013
Basic UDI-DI: 6970277510014PYS
Reference: ISTB-N502H-07
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178020
Basic UDI-DI: 6970277510014PYS
Reference: ISTB-N502H-10
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Safety summary (SSCP/SSP): RTD001702-SSP · Rev. 06
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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