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00816467020327

FastPack Total PSA Calibrator 25s Kit

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020327
Basic UDI-DI: B-00816467020327
Reference: 25000077
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

00816467020105

FastPack hCG Calibrator Kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020105
Basic UDI-DI: B-00816467020105
Reference: 25000035
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

00816467020099

FastPack TSH Calibrator Kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020099
Basic UDI-DI: B-00816467020099
Reference: 25000024
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

00816467020068

FastPack FreeT4 Calibrator Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020068
Basic UDI-DI: B-00816467020068
Reference: 25000016
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Lipoprotein(a) Calibrator

DX_LS_LEGACY_00630414558257

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414558257
Basic UDI-DI: B-00630414558257
Reference: 10285017
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Liquid Specific Protein Calibrators

DX_LS_LEGACY_00630414482453

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414482453
Basic UDI-DI: B-00630414482453
Reference: 10311929
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Squamous Cell Carcinoma Calibrator (SCC CAL)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414622811
Basic UDI-DI: 0405686902366VW
Reference: 11553961
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Free Prostate-Specific Antigen Calibrator (fPSA CAL)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414290577
Basic UDI-DI: 0405686901479W5
Reference: 11203743
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.09.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

Urine DoA EDDP Calibrators

Methadone Metabolite (EDDP)

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08059307640596
Basic UDI-DI: 80593076404595P
Reference: 0018541800
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 21:38

Manufacturer products View details

TDM CALIBRATOR

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

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175710
Basic UDI-DI: 5204309000104NP
Reference: 1578-0606
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: -
Last updated: 21.09.2026 21:20

Manufacturer products View details

IgE Control Pack

0.5mL x 2 vials x 2 levels / Pack

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Beijing Medconn Medical Devices Co.,Ltd.
Manufacturer SRN: CN-MF-000052044
UDI-DI: 06974704727935
Basic UDI-DI: B-06974704727935
Reference: 42101021
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Kingsmead Service B.V.
Last updated: 21.09.2026 17:53

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D Calibrator Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G4583930013P
Basic UDI-DI: B-G4583930013P
Reference: 393 001
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.08.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-A00738T3

N/A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A00738T3
Basic UDI-DI: B-A00738T3
Reference: A00738
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:28

Manufacturer products View details

D-A00737SZ

N/A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-A00737SZ
Basic UDI-DI: B-A00737SZ
Reference: A00737
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 11.08.2026 23:28

Manufacturer products View details

Lipoprotein (a) Molarity Assay Calibrator Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Diazyme Laboratories, Inc.
Manufacturer SRN: US-MF-000025166
UDI-DI: 00817089024328
Basic UDI-DI: 0817089024328XT
Reference: DZ098A-CAL
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 11.08.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL)

IVDR_67_TTN_DUB-C_B_REAG_RCRP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611297
Basic UDI-DI: 0405686902329VQ
Reference: 11537245
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Phenobarbital Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Phenobarbital Calibrators

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017414
Basic UDI-DI: 0405686901160UZ
Reference: 10445307
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator B

IVDR_67_TTN_DUB-C_C_REAG_Cal B

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414504773
Basic UDI-DI: 0405686901830VT
Reference: 10331729
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur CA 125II Calibrator

IVDR_67_TTN_DUB-C_C_REAG_CA 125II Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461335
Basic UDI-DI: 0405686901828W8
Reference: 10310444
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur CKMB Calibrator

IVDR_67_TTN_DUB-C_C_REAG_CKMB Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414124803
Basic UDI-DI: 0405686901905VZ
Reference: 10311570
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details