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ARCHITECT

ARCHITECT LH

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

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740003913
Basic UDI-DI: 038074ARP0240NY
Reference: 02P4001
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

ARCHITECT

ARCHITECT HE4

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740003975
Basic UDI-DI: 038074ARP0254PB
Reference: 02P5401
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

ARCHITECT

ARCHITECT Anti-CCP

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740002022
Basic UDI-DI: 038074ARP0165PB
Reference: 01P6501
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

ARCHITECT

ARCHITECT ProGRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740001971
Basic UDI-DI: 038074ARP0145P5
Reference: 01P4527
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 12:00

Manufacturer products View details

RapidFor™

SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595037232
Basic UDI-DI: 868354825VMD79SC4C
Reference: VMD79SC01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 11:50

Manufacturer products View details

AMH Control

Analyzer (automatic and non-automatic)

IVD Class BIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050027
Basic UDI-DI: 697492505000001T4
Reference: BYZKA0103
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

AcuteckTM Blood Glucose Test Strips

Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804819491
Basic UDI-DI: 69528048GHP-101ProSKZ9
Reference: C902005-100
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): TH-R025-9.3 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Kloakmedie

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106999608
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 99960
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 11:04

Manufacturer products View details

3PLUS1® Multilevel Plasma Calibrator Set

MassTox® TDM Series A PARAMETER Set Antimycotic Drugs/EXTENDED in serum/plasma

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317548573
Basic UDI-DI: 425031792922XTR6
Reference: 92051/XT
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:51

Manufacturer products View details

MassChrom® Biogenic Amines/Metabolites in urine Sample Prep Set Total Metanephrines (free + conjugated) with Sample Clean Up Columns

MassChrom® Biogenic Amines/Metabolites in urine Sample Prep Set Total Metanephrines (free + conjugated)

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317537546
Basic UDI-DI: 4250317807006F
Reference: 80700/C
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:51

Manufacturer products View details

Internal Standard Set

MassTox® TDM Series A PARAMETER Set Neuroleptics 1/EXTENDED in serum/plasma

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317535009
Basic UDI-DI: 425031792912XTQX
Reference: 92046/AN1/XT
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:51

Manufacturer products View details

96 Deep Well Extraction Plates

MassTox® Immunosuppressants in whole blood

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317533661
Basic UDI-DI: 4250317930006C
Reference: 93956
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:51

Manufacturer products View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 05903205791436
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-011
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:45

Manufacturer products Open in EUDAMED View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 08436565983434
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-004
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:45

Manufacturer products Open in EUDAMED View details

autotest VIH® 2nd GENERATION

IVD Class DIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 09003622006062
Basic UDI-DI: 3770011742ASVIH0501002U
Reference: AS-VIH-014
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: -
Safety summary (SSCP/SSP): AAZ.AV.106 · Rev. C
Authorised representative: -
Last updated: 23.09.2026 10:44

Manufacturer products Open in EUDAMED View details

NG Precision+

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077401864
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-014
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 23.09.2026 10:31

Manufacturer products View details

LyoSens™

LYO188WS24

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529503
Basic UDI-DI: 868521452PCR188GU
Reference: LYO188WS24
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT DHEA-S

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740160722
Basic UDI-DI: 038074ARK0827NF
Reference: 08K2702
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT SHBG

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740156053
Basic UDI-DI: 038074ARK0826ND
Reference: 08K2602
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details

ARCHITECT

ARCHITECT Intact PTH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740156022
Basic UDI-DI: 038074ARK0825NB
Reference: 08K2513
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 10:28

Manufacturer products View details