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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 13:11

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232 device results listed.

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ichroma™ PCT Plus G

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

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

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730342
Basic UDI-DI: 697447273034MQ
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730335
Basic UDI-DI: 697447273033MN
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730328
Basic UDI-DI: 697447273032ML
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730311
Basic UDI-DI: 697447273031MJ
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730304
Basic UDI-DI: 697447273030MG
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730298
Basic UDI-DI: 697447273029MX
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730281
Basic UDI-DI: 697447273028MV
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ B·R·A·H·M·S PCT

HOKAPI™ B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405295
Basic UDI-DI: 69713904310047H
Reference: 011004001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin(CLIA)

105-010703-00、105-010730-00、105-010219-00、105-010228-00、105-010248-00、105-010238-00、 105-010258-00

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: 06936415900588
Basic UDI-DI: 69449040004S-PCT*******M3
Reference: 105-010703-00
EMDN: W0102069013
EMDN description: PROCALCITONIN
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

VIDAS® B•R•A•H•M•S PCT™

-

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026620882
Basic UDI-DI: 357302BUDI000011SF
Reference: 30450-30
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 03:35

Manufacturer products View details

C22593

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590719531
Basic UDI-DI: 150995903AccPCTQA
Reference: C22593
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:50

Manufacturer products View details

STANDARD™ i PCT

i-PCT-01

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722028
Basic UDI-DI: 88001117IPCA01IA11WF
Reference: 16PCT10Q
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i PCT

i-PCT-01

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722011
Basic UDI-DI: 88001117IPCA01IA11WF
Reference: 16PCT10F
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i PCT

i-PCT-01

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722004
Basic UDI-DI: 88001117IPCA01IA11WF
Reference: 16PCT10D
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Procalcitonin

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025774
Basic UDI-DI: 697648502PCT2RD
Reference: 30-2257 200 tests/kit
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Procalcitonin

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025767
Basic UDI-DI: 697648502PCT2RD
Reference: 20-2257 100 tests/kit
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Procalcitonin

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025750
Basic UDI-DI: 697648502PCT2RD
Reference: 10-2257 40 tests/kit
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485022919
Basic UDI-DI: 697648502PCTWG
Reference: 20-2067 100 tests/kit
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details