Biochemistry Pathological Control

Ref HBC02

Biochemistry Pathological Control (HBC02) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category assayed multicomponent controls (cc)) made by Cypress Diagnostics, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI B-05404035101377), active as of 25 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05404035101377 Basic UDI-DI 05404035101377UDI-DI	Date30 Mar 2026Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-05404035101377 — open Devices and search for it

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Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference: HBC02

Primary DI / UDI-DI: 05404035101377
Basic UDI-DI: B-05404035101377
EMDN code: W0101050101 Assayed multicomponent controls (cc)

Device class: Class IVD General
EU registration type: Legacy device (under a directive)
EU market of registration: Belgium

Manufacturer details

EUDAMED SRN: BE-MF-000000033

From the manufacturer

Manufacturer's product page: Good Practices in Biochemistry Quality Control

Similar devices in this category

Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).

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Properties

Contains human tissues or cells
Reagent
IVD kit
Professional testing

Other properties (8, all answered No)