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222 device results listed.

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D-02B0026YT

Pepsinogen I/Pepsinogen II Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0026YT
Basic UDI-DI: B-02B0026YT
Reference: 2X001
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen II Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465234350
Basic UDI-DI: 697846523ProteinB06RJ
Reference: 2×100 test
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465234251
Basic UDI-DI: 697846523ProteinB05RG
Reference: 2×100 test
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG II

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404670
Basic UDI-DI: 69713904301167N
Reference: 010116001
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG I

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404656
Basic UDI-DI: 69713904301157L
Reference: 010115001
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅱ (CLIA)

105-010087-00、105-010097-00、105-010137-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900489
Basic UDI-DI: 69449040004V-PG2*******7T
Reference: 105-010087-00
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I (CLIA)

105-010086-00、105-010096-00、105-010136-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900465
Basic UDI-DI: 69449040004V-PG1*******78
Reference: 105-010086-00
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439722
Basic UDI-DI: 69713904301167N
Reference: 010116101
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG I

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439715
Basic UDI-DI: 69713904301157L
Reference: 010115101
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen II (Electrochemiluminescence Immunoassay)

50T