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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 16:25

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232 device results listed.

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Procalcitonin (PCT) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-001NX
Basic UDI-DI: B-K90411-001NX
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408301JR
Basic UDI-DI: B-IM4408301JR
Reference: IM4408301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407301JJ
Basic UDI-DI: B-IM4407301JJ
Reference: IM4407301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406301JB
Basic UDI-DI: B-IM4406301JB
Reference: IM4406301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:27

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4405301J4
Basic UDI-DI: B-IM4405301J4
Reference: IM4405301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404301HV
Basic UDI-DI: B-IM4404301HV
Reference: IM4404301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403301HN
Basic UDI-DI: B-IM4403301HN
Reference: IM4403301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402301HF
Basic UDI-DI: B-IM4402301HF
Reference: IM4402301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401301H8
Basic UDI-DI: B-IM4401301H8
Reference: IM4401301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GDPCT-T402aHGS6
Basic UDI-DI: B-GDPCT-T402aHGS6
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T402aC6
Basic UDI-DI: B-GDPCT-T402aC6
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Strip (Whole Blood/Serum/Plasma)

GDPCT-T401a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T401aC3
Basic UDI-DI: B-GDPCT-T401aC3
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-402a5B
Basic UDI-DI: B-GDPCT-402a5B
Reference: GDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BRAHMS Procalcitonin (PCT)

-

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246550
Basic UDI-DI: 0405686901818W5
Reference: 11202699
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Quantitative Test Kit (Time-Resolved FIA)

FDPCT-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDPCT-402aHG5U
Basic UDI-DI: B-FDPCT-402aHG5U
Reference: FDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Quantitative Test Kit (Time-Resolved FIA)

PCT Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPCT-402a4E
Basic UDI-DI: B-FDPCT-402a4E
Reference: FDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Test Kit (Immunofluorescence)

50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0017Z9
Basic UDI-DI: B-FA0017Z9
Reference: 52027007
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4103071EM
Basic UDI-DI: B-EIM4103071EM
Reference: EIM4103071
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4102071EE
Basic UDI-DI: B-EIM4102071EE
Reference: EIM4102071
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101071E7
Basic UDI-DI: B-EIM4101071E7
Reference: EIM4101071
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details