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FT3 Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762612
Basic UDI-DI: 697134876223B2612YT
Reference: MF-223
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762605
Basic UDI-DI: 697134876216B2605ZL
Reference: MF-216
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

fPSA Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762599
Basic UDI-DI: 697134876247C25994Y
Reference: MF-247
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

FERR Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762582
Basic UDI-DI: 697134876212B2582YD
Reference: MF-212
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762568
Basic UDI-DI: 697134876228C25683Y
Reference: MF-228
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH VD Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762551
Basic UDI-DI: 697134876242B2551ZM
Reference: MF-242
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Gastrin Control Module

IVDR_67_LLB_DUB-C_B_REAG_Gastrin Control Module

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953199
Basic UDI-DI: 0405686901427VJ
Reference: 10385331
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Emit LSD Control Level 2

IVDR_67_GLA_DUB-C_B_REAG_LSD Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002106
Basic UDI-DI: 0405686901143UZ
Reference: 10445461
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BNP Calibrator (BNP Cal)

IVDR_67_TTN_DUB-C_C_REAG_BNP_Cal

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472836
Basic UDI-DI: 0405686900812VJ
Reference: 10309047
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BNP 1,2,3 Quality Control

IVDR_67_TTN_DUB-C_C_REAG_BNP_QC

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472829
Basic UDI-DI: 0405686900813VL
Reference: 10309046
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Protein Abnormal Control

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025795
Basic UDI-DI: 505601300ULTCESPCONTTU
Reference: V120
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Caffeine Control

IVDR_67_GLA_DUB-C_C_REAG_Caffeine Control

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001420
Basic UDI-DI: 0405686901070UX
Reference: 10445372
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Estradiol Control Module

IVDR_67_LLB_DUB-C_C_REAG_Estradiol Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414974095
Basic UDI-DI: 0405686901477VZ
Reference: 10389765
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 HCG

IVDR_67_LLB_DUB-C_C_KIT_HCG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961132
Basic UDI-DI: 0405686901453VK
Reference: 10381206
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Drug Control Module

IVDR_67_LLB_DUB-C_C_REAG_Serum Drug Control Module

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953410
Basic UDI-DI: 0405686901488W6
Reference: 10385397
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE HCG High Level Control Module

IVDR_67_LLB_DUB-C_C_REAG_HCG Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953205
Basic UDI-DI: 0405686901481VQ
Reference: 10385358
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE C-Reactive Protein Control Module

IVDR_67_LLB_DUB-C_C_REAG_C-Reactive Protein Con Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953144
Basic UDI-DI: 0405686900354V9
Reference: 10385316
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur cPSA 1,2,3 Quality Control Material

IVDR_67_TTN_DUB-C_C_REAG_cPSA QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451732
Basic UDI-DI: 0405686901840VW
Reference: 10310387
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (PCT CAL)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238708
Basic UDI-DI: 0405686902023UV
Reference: 11354448
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-A073DA

INDICAID® AMH Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A073DA
Basic UDI-DI: B-A073DA
Reference: INDICAID® AMH Rapid Test
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details