Histareader501-1

by RefLab Aps Denmark EUDAMED

Ref RLA501-1Model 501 EMDN W0201020280

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number574400328READER8M Basic UDI-DI	Date17 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name: Histareader501
Model / Reference: 501, RLA501-1

Primary DI / UDI-DI: 05744003280025
Basic UDI-DI: 574400328READER8M
EMDN Code: W0201020280 Limited panel immunochemistry analysers - hardware accessories

Device Class: Class A
Market of Registration: Denmark

Manufacturer details

EUDAMED SRN: DK-MF-000021844

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Properties & raw data

Show properties, registry sources and raw records

Professional Testing
Surgical Instrument

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
New Device: No

Sources (1)

EUDAMED 6342c01a-27a6-4269-be83-c25c2e6d360b 61 fields · synced 25 Oct 2026