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699 device results listed.

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VivaDiag Infection Combo (PCT/IL-6/CRP) Test Kit (FIA)

VID109

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID109EX
Basic UDI-DI: B-VID109EX
Reference: VID109-01-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Test Kit (FIA)

VID02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID022K
Basic UDI-DI: B-VID022K
Reference: VID02-01-011
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-544C

Gastrin-17 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-544C
Basic UDI-DI: B-TD-HNKX-CED-544C
Reference: /
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-454B

Pepsinogen I & Pepsinogen II Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-454B
Basic UDI-DI: B-TD-HNKX-CED-454B
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-1848

Procalcitonin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-1848
Basic UDI-DI: B-TD-HNKX-CED-1848
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Luteinizing Hormone (LH)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599533
Basic UDI-DI: 0405686901617VR
Reference: 10995635
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Prolactin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177274
Basic UDI-DI: 0405686901623VL
Reference: 10309976
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Progesterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414454641
Basic UDI-DI: 0405686901624VN
Reference: 10315522
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Luteinizing Hormone (LH)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599526
Basic UDI-DI: 0405686901617VR
Reference: 10995634
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

PGIl Pepsinogen ll (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PGII706-AE46
Basic UDI-DI: B-PGII706-AE46
Reference: PGII706-AE10Y, PGII706-AE10N, PGII706-AE20Y, PGII706-AE20N
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

PGI Pepsinogen l (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PGI706-AEZD
Basic UDI-DI: B-PGI706-AEZD
Reference: PGI706-AE10Y, PGI706-AE10N, PGI706-AE20Y, PGI706-AE20N
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Procalcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PCT706-AE4X
Basic UDI-DI: B-PCT706-AE4X
Reference: PCT706-AE10Y, PCT706-AE10N, PCT706-AE20Y, PCT706-AE20N
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:42

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: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T402aBZ
Basic UDI-DI: B-OGGDPCT-T402aBZ
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 06:12

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 marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T401aBW
Basic UDI-DI: B-OGGDPCT-T401aBW
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 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PG II CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PGII-01100CG9
Basic UDI-DI: B-KR-PGII-01100CG9
Reference: KR-PG Ⅱ-01100C
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PGI CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PGI-01100C27
Basic UDI-DI: B-KR-PGI-01100C27
Reference: KR-PGⅠ-01100C
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX G-17 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-G-17-0250WW
Basic UDI-DI: B-KR-G-17-0250WW
Reference: KR-G-17-0250
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX G-17 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-G-17-02200VD
Basic UDI-DI: B-KR-G-17-02200VD
Reference: KR-G-17-02200
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX G-17 CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-G-17-01100UZ
Basic UDI-DI: B-KR-G-17-01100UZ
Reference: KR-G-17-01100
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-K91201-0346

PCT-BP

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-0346
Basic UDI-DI: B-K91201-0346
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details