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EUDAMED Device Search

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

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01.08.2026 18:27

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618 device results listed.

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50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334800668
Basic UDI-DI: B-06950334800668
Reference: 32027066
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Pepsinogen II (CLIA)

PG II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502195
Basic UDI-DI: B-06947145502195
Reference: 130201020M
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI PG I (CLIA)

PG I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502171
Basic UDI-DI: B-06947145502171
Reference: 130201019M
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8302CRP

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026344
Basic UDI-DI: B-06945429026344
Reference: CH8302CRP
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8301CRP

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026337
Basic UDI-DI: B-06945429026337
Reference: CH8301CRP
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8300CRP

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026320
Basic UDI-DI: B-06945429026320
Reference: CH8300CRP
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8312

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026313
Basic UDI-DI: B-06945429026313
Reference: CH8312
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8311

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026306
Basic UDI-DI: B-06945429026306
Reference: CH8311
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8310

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026290
Basic UDI-DI: B-06945429026290
Reference: CH8310
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8302

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026283
Basic UDI-DI: B-06945429026283
Reference: CH8302
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8301

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026276
Basic UDI-DI: B-06945429026276
Reference: CH8301
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8300

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026269
Basic UDI-DI: B-06945429026269
Reference: CH8300
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8502CRP

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026252
Basic UDI-DI: B-06945429026252
Reference: CH8502CRP
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8501CRP

IVD generalIVDDOn the marketInstrumentSingle use

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429026245
Basic UDI-DI: B-06945429026245
Reference: CH8501CRP
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Iceland
Authorised representative: Lotus NL B.V.
Last updated: 27.06.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅱ CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359509145
Basic UDI-DI: 697015090000230H3
Reference: CMB1610
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅰ CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359509091
Basic UDI-DI: 697015090000229HJ
Reference: CMB1510
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

G17 CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590872
Basic UDI-DI: 697518250F13005ZV
Reference: F13005
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen II CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590797
Basic UDI-DI: 697518250P130045Y
Reference: F13004
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590780
Basic UDI-DI: 697518250P130035W
Reference: F13003
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590308
Basic UDI-DI: 697518250F1500126
Reference: F15008
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details