FIAPresto FIAVet

by Bifour Biotech Inc.

Ref FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number08600102462BBIITRI001AN Basic UDI-DI 00860010246207UDI-DI	Date12 May 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Time-resolved immunofluorescence analyzer
Model / Reference: FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)

Primary DI / UDI-DI: 00860010246207
Basic UDI-DI: 08600102462BBIITRI001AN
Direct Marketing DI: 00860010246207
EMDN Code: W0201020101, W0201020102, W0201020103, W0201020104, W0201020180, W0201020182, W0201020185, W0201020192

Device Class: Class A
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: US-MF-000034957
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Bifour Biotech Inc.

Real-time fluorescence quantitative PCR instrument

Class A
Automated Nucleic Acid Extractor

Class A

Properties

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