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ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175634
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3210
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

IDS High Sensitive Estradiol Control Set

IDS High Sensitive Estradiol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690899
Basic UDI-DI: 5060169693630XP
Reference: IS-5230HS
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 22.09.2026 01:53

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

ARCHITECT NSE

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175627
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 00:03

Manufacturer products View details

α1-Microglobulin Calibrator Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503610102
Basic UDI-DI: 4987503A1MGUcal6J
Reference: 08944474190
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

ARK Meperidine Calibrator

5039-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030141
Basic UDI-DI: B-00812101030141
Reference: 5039-0002-00
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 13.08.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Calibrator

5039-0002-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030158
Basic UDI-DI: B-00812101030158
Reference: 5039-0002-01
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 13.08.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Calibrator

5039-0002-02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030165
Basic UDI-DI: B-00812101030165
Reference: 5039-0002-02
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 13.08.2026 10:54

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