Specimen Collection Kit

by Agendia N.V Netherlands EUDAMED

Ref ESM107.01, NLT105.01, DUS108.01Model Agendia ES FFPE W/Slides, Agendia NL FFPE W/Slides, Agendia DUS FFPE W/Slides

EMDN W05020102

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number0850024841ESM107QL Basic UDI-DI	Date13 Apr 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference: Agendia ES FFPE W/Slides, ESM107.01, Agendia NL FFPE W/Slides, NLT105.01, Agendia DUS FFPE W/Slides, DUS108.01

Primary DI / UDI-DI: 00850024841260, 00850024841246, 00850024841345
Basic UDI-DI: 0850024841ESM107QL, 0850024841NLT105T9, 00850024841DUSF108VG
EMDN Code: W05020102 Samples transport, boxes

Device Class: Class A
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: NL-MF-000011684

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Specimen Collection Kit

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Properties & raw data

Show properties, registry sources and raw records

New Device NoEUDAMEDYesEUDAMED

Other properties (10)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (3)

EUDAMED c0036827-e726-49fb-a5ae-51109d7be2ca 61 fields · synced 23 Oct 2026
EUDAMED 00850024841246|0850024841NLT105T9 61 fields · synced 18 May 2026
EUDAMED 00850024841345|00850024841DUSF108VG 61 fields · synced 18 May 2026