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N Apolipoprotein Standard Serum

IVDR_27_MAR EB_B_REAG_N_Apo_Stand

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768011528
Basic UDI-DI: 0405686900956WB
Reference: 10446465
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

N Protein Standard PY

IVDR_27_MAR EB_C_REAG_N_Prot_Stand_PY

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768011375
Basic UDI-DI: 0405686900965WC
Reference: 10446449
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

N Lp(a) Standard SY

IVDR_27_MAR EB_B_REAG_N_Lpa_Stand_SY

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007224
Basic UDI-DI: 0405686900888WK
Reference: 10446038
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

Dimension Vista PROT2 CAL

IVDR_67_MAR EB_C_REAG_V_PROT2_CAL

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006463
Basic UDI-DI: 0405686900924VW
Reference: 10445935
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

Atellica IM B‑Type Natriuretic Peptide 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: 00630414598000
Basic UDI-DI: 0405686900812VJ
Reference: 10995473
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator A (CAL A)

IVDR_67_TTN_DUB-C_B_REAG_CAL A

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414555324
Basic UDI-DI: 0405686900774W3
Reference: 10285904
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator U (Cal U)

IVDR_67_TTN_DUB-C_C_REAG_CAL U

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414178493
Basic UDI-DI: 0405686900814VN
Reference: 10309996
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
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

Emit 2000 Mycophenolic Acid Calibrators

IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414168272
Basic UDI-DI: 0405686900732VK
Reference: 10730959
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
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

Dimension Tacrolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TAC_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768035432
Basic UDI-DI: 0405686900215US
Reference: 10700796
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

N FLC Standard SL

IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Stand_SL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031441
Basic UDI-DI: 0405686900183V6
Reference: 10482440
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

Manufacturer products View details

N Rheumatology Standard SL

IVDR_27_MAR EB_C_PROF_REAG_N_RF_Stand_SL

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007798
Basic UDI-DI: 0405686900188VG
Reference: 10446099
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

Manufacturer products View details

N Protein Standard SL

IVDR_27_MAR EB_C_PROF_REAG_N_Prot_Stand_SL

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007590
Basic UDI-DI: 0405686900187VE
Reference: 10446073
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:06

Manufacturer products View details

Emit 2000 Mycophenolic Acid Controls

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid controls

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001512
Basic UDI-DI: 0405686900213UN
Reference: 10445381
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001505
Basic UDI-DI: 0405686900212UL
Reference: 10445380
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

ARCHITECT iPhenytoin

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740001797
Basic UDI-DI: 038074ARP0134NY
Reference: 01P3401
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 15.07.2026 23:23

Manufacturer products View details

ARCHITECT

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740001803
Basic UDI-DI: 038074ARP0134NY
Reference: 01P3425
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 23:01

Manufacturer products View details

LZI Methadone Metabolite (EDDP) 100 Low Calibrator (50 ng/mL)

Methadone Metabolite Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: B0760202B0
Basic UDI-DI: ++B076CCEDDP01HT
Reference: 0202b
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator Q (CAL Q)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598444
Basic UDI-DI: 0405686901832VX
Reference: 10995517
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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 SHBG Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603407
Basic UDI-DI: 0405686901770W2
Reference: 10997192
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
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 Calibrator Q (CAL Q)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414202938
Basic UDI-DI: 0405686901832VX
Reference: 10310295
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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