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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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03.08.2026 06:01

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633 device results listed.

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PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062990
Basic UDI-DI: 69703416803205093JU
Reference: 0320510402
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063003
Basic UDI-DI: 69703416803205093JU
Reference: 0320510403
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063010
Basic UDI-DI: 69703416803205093JU
Reference: 0320510404
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044469
Basic UDI-DI: 88061330BD09JB
Reference: CFPC-23-1
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS PCT Plus G

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044414
Basic UDI-DI: 880613300612C8
Reference: SMFP-112
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT Plus G

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044377
Basic UDI-DI: 880613300128BW
Reference: CFPC-136
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS FECAL ELASTASE

FEL-C

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322786
Basic UDI-DI: 803389132FEL-C007J
Reference: 86114
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:18

Manufacturer products View details

CHORUS CLIA FECAL ELASTASE

CFEL

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

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891328474
Basic UDI-DI: 803389132CFEL005H
Reference: 82304
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:15

Manufacturer products View details

Elafast®

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

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208411
Basic UDI-DI: 802816920BW01020608053R
Reference: 9191EP
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:39

Manufacturer products View details

Gastrin-17 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: 06978465234558
Basic UDI-DI: 697846523ProteinB07RL
Reference: 2×100 test
EMDN: W0102069001
EMDN description: GASTRIN
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 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

Procalcitonin 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: 06978465232950
Basic UDI-DI: 697846523ProteinB03RC
Reference: 2×100 test
EMDN: W0102069013
EMDN description: PROCALCITONIN
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

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000