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IMMULITE 2000 Prolactin

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961941
Basic UDI-DI: 0405686901402V2
Reference: 10381199
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

CysC Quantitative Test Kit (Time-Resolved FIA)

FICYS-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FICYS-402aHGE5
Basic UDI-DI: B-FICYS-402aHGE5
Reference: FICYS-402a
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

CysC Quantitative Test Kit (Time-Resolved FIA)

FICYS-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FICYS-402aBK
Basic UDI-DI: B-FICYS-402aBK
Reference: FICYS-402a
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-FI-MXA-402VJ

MxA Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-MXA-402VJ
Basic UDI-DI: B-FI-MXA-402VJ
Reference: FI-MXA-402
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 21:28

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Calprotectin Quantitative Test Kit (Time-Resolved FIA)

FDCAL-602a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDCAL-602aQQ
Basic UDI-DI: B-FDCAL-602aQQ
Reference: FDCAL-602a
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Quantitative Test Kit (Time-Resolved FIA)

FDCAL-602a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FDCAL-602aHGLL
Basic UDI-DI: B-FDCAL-602aHGLL
Reference: FDCAL-602a
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05030626T

α1-Microglobulin (α1-MG)