Buffered Formalin Concentrate

by Atom Scientific Ltd EUDAMED

Active European Union

Ref RRFF5000-GModel Cytology Fixative Solution

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number505591470RRFFEK Basic UDI-DI	Date27 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference: Cytology Fixative Solution, RRFF5000-G

Primary DI / UDI-DI: 05060405297325
Basic UDI-DI: 505591470RRFFEK
EMDN Code: W01030705 Fixing reagents (histology/cytology)

Device Class: Class A
Market of Registration: Northern Ireland

Manufacturer details

EUDAMED SRN: UK-MF-000046578
Authorised representative: Advena Limited MT-AR-000000234

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Properties

Reagent
Professional Testing

Other properties (9)

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