Access Sensitive Estradiol Calibrator S0

by Beckman Coulter Inc. United States EUDAMED

Ref B97145

EMDN W0102152299

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number150995901AccSE2S0CalMV Basic UDI-DI	Date2 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: B97145

Primary DI / UDI-DI: 15099590699406, 15099590817824
Basic UDI-DI: 150995901AccSE2S0CalMV, 150995909AccSE2S0CalX5
EMDN Code: W0102152299, W0102152205

Device Class: Class B
Market of Registration: Ireland

Manufacturer details

EUDAMED SRN: US-MF-000010288
Authorised representative: Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Reagent
Professional Testing
New Device NoEUDAMEDYesEUDAMED

Other properties (7)

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

Sources (2)

EUDAMED 6c06e6f8-de96-4e14-9d5d-b85f1c1dcacc 61 fields · synced 22 Oct 2026
EUDAMED 15099590817824|150995909ACCSE2S0CALX5 61 fields · synced 8 Oct 2026