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Emit 2000 Mycophenolic Acid Controls

IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid_Cnt

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414168289
Basic UDI-DI: 0405686900733VM
Reference: 10730960
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM High-Sensitivity Troponin I Master Curve Material (TnIH MCM)

IVDR_67_TTN_DUB-C_C_REAG_TnIH_MCM

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414006772
Basic UDI-DI: 0405686900834VU
Reference: 10997842
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

N FLC Control SL1

IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Con_SL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031458
Basic UDI-DI: 0405686900182V4
Reference: 10482441
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

Manufacturer products View details

Apolipoprotein Control Serum CHD

IVDR_27_MAR EB_C_PROF_REAG_Apo_Con_CHD

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768011559
Basic UDI-DI: 0405686900139V3
Reference: 10446468
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

Manufacturer products View details

N/T Protein Control SL/L

IVDR_27_MAR EB_C_PROF_REAG_NT_Prot_Con

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007613
Basic UDI-DI: 0405686900189VJ
Reference: 10446076
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:06

Manufacturer products View details

N/T Rheumatology Control SL/1

IVDR_27_MAR EB_C_PROF_REAG_NT_RF_Con

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007262
Basic UDI-DI: 0405686900190V3
Reference: 10446041
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:06

Manufacturer products View details

N Protein Control LC1

IVDR_27_MAR EB_C_PROF_REAG_N(T)_Prot_Con_LC

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768000706
Basic UDI-DI: 0405686900186VC
Reference: 10446021
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:06

Manufacturer products View details

IMMULITE 3gAllergy Specific IgE Negative Control Module

IVDR_67_LLB_DUB-C_C_REAG_3gAllergy Spfc IgE Neg Cnt Mod

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414984599
Basic UDI-DI: 0405686900233UU
Reference: 10485107
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 3gAllergy Specific IgE Positive Control for MC6L Module

IVDR_67_LLB_DUB-C_C_REAG_3gAllergy Spfc IgE Pos Cnt M6

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414984582
Basic UDI-DI: 0405686900236V2
Reference: 10485106
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 3gAllergy Specific IgE Positive Control for D2 Module

IVDR_67_LLB_DUB-C_C_REAG_3gAllergy Spfc IgE Pos Cnt D2

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414984575
Basic UDI-DI: 0405686900235UY
Reference: 10485105
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 3gAllergy Specific IgE Positive Control for D1 Module

IVDR_67_LLB_DUB-C_C_REAG_3gAllergy Spfc IgE Pos Cnt D1

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414984568
Basic UDI-DI: 0405686900234UW
Reference: 10485104
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

801mm

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135495
Basic UDI-DI: 008500111358017M
Reference: 801mm
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 15.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare™ PSA Control

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: D-W814JU
Basic UDI-DI: B-W814JU
Reference: W814-L, W814-M, W814-H
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 13:29

Manufacturer products Authorised representative products Authorised representative actors View details

FDWCR-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-W0102152003CN
Basic UDI-DI: B-W0102152003CN
Reference: FDWCR-PN20
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 15-3 Control Solution (FIA)

VIC97

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC973K
Basic UDI-DI: B-VIC973K
Reference: VIC97-06-011
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

H.Pylori Antigen Control Solution (FIA)

VIC83

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC8338
Basic UDI-DI: B-VIC8338
Reference: VIC83-01-011
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
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

H.Pylori Antibody Control Solution (FIA)

VIC82

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC8236
Basic UDI-DI: B-VIC8236
Reference: VIC82-01-011
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
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

B-type Brain Natriuretic Peptide Control Solution (FIA)

VIC81

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC8134
Basic UDI-DI: B-VIC8134
Reference: VIC81-01-011
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Pregnanediol-3-Glucuronide Control Solution (FIA)

VIC75

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC7539
Basic UDI-DI: B-VIC7539
Reference: VIC75-05-011
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
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

Aldosterone Control Solution (FIA)

VIC68

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC683C
Basic UDI-DI: B-VIC683C
Reference: VIC68-05-011
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
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