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REP/SPIFE SP 600 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011538
Basic UDI-DI: 5056013005BANDM8
Reference: 3145
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 300 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011552
Basic UDI-DI: 5056013005BANDM8
Reference: 3146
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 180 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011569
Basic UDI-DI: 5056013005BANDM8
Reference: 3147
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

06935784400286

1 Test/Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784400286
Basic UDI-DI: B-06935784400286
Reference: COM-S0101E0
EMDN: W0102019005
EMDN description: FIBRONECTIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Total Testosterone

IVDR_67_LLB_DUB-C_B_REAG_KIT_Total Testosterone

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962221
Basic UDI-DI: 0405686901414V9
Reference: 10381191
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

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IMMULITE 2000 Progesterone

IVDR_67_LLB_DUB-C_B_KIT_Progestrne

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961972
Basic UDI-DI: 0405686901401UY
Reference: 10381181
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S225RR

BF S22

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S225RR
Basic UDI-DI: B-CNMF000014455-BF-S225RR
Reference: BF-S225
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S224RP

BF S22

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S224RP
Basic UDI-DI: B-CNMF000014455-BF-S224RP
Reference: BF-C244
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S222RK

BF S22

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S222RK
Basic UDI-DI: B-CNMF000014455-BF-S222RK
Reference: BF-S222
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S221RH

BF S22

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S221RH
Basic UDI-DI: B-CNMF000014455-BF-S221RH
Reference: BF-S221
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

Faecal Calprotectin Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309126
Basic UDI-DI: B-69743840309126
Reference: 3051001
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Onco Biomedical Technology (Suzhou) Co.,Ltd.
Manufacturer SRN: CN-MF-000047590
UDI-DI: D-69328692FI001MCGK
Basic UDI-DI: B-69328692FI001MCGK
Reference: PSEP-1030001T
EMDN: W0102019007
EMDN description: IMMUNO REACTIVE TRYPSIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Prostatic Exosomal Protein Qualitative Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Onco Biomedical Technology (Suzhou) Co.,Ltd.
Manufacturer SRN: CN-MF-000047590
UDI-DI: D-69328692CG001KVF6
Basic UDI-DI: B-69328692CG001KVF6
Reference: PSEP-1030001T
EMDN: W0102019007
EMDN description: IMMUNO REACTIVE TRYPSIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-96AZ

Serum Amyloid A(SAA)Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-96AZ
Basic UDI-DI: B-6-96AZ
Reference: "REF: USIA00000071M, USIA00000072M"
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-46AJ

β2-Microglobulin (β2-MG) testing kit (latex immunoturbidimetric method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-46AJ
Basic UDI-DI: B-6-46AJ
Reference: "REF: U85782020M, U85781040M, U85789060M, U85785020M, U85720060M"
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-17AB

Adenosine Deaminase Test Kit (Peroxidase Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-17AB
Basic UDI-DI: B-6-17AB
Reference: "REF: U81382045M, U81389045M, U81385015M, U81320045M"
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-134FH

Serum amyloid A(SAA)Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-134FH
Basic UDI-DI: B-6-134FH
Reference: "REF: USCA00000745, USCA00000748 USCA00000746 USCA00000747, USCA00000749"
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

OROSOMUCOID IP

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700823117
Basic UDI-DI: 37017008IORO03DD
Reference: IORO-6125
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

OROSOMUCOID IP

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700823124
Basic UDI-DI: 37017008IORO03DD
Reference: IORO-5025
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

Cystatin C Gold Latex

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168016117
Basic UDI-DI: B-05415168016117
Reference: CYDGX-H00/UDA
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 17:55

Manufacturer products View details