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Organization name
UDI-DI code
Reference / catalog number

HbA1c Calibrator — IVDD — General IVDD by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Mar 23, 2026

HbA1c Calibrator

B-05404035101711

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035101711
Reference / catalog number: HT001S

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Manufacturer information

Organization name: Cypress Diagnostics
SRN: BE-MF-000000033
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
See IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: HbA1c Calibrator
UDI-DI code: 05404035101711
Basic UDI-DI: B-05404035101711
Reference / catalog number: HT001S
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Cypress Diagnostics kit HbA1c Calibrator is an in vitro diagnostic medical device intended to be used for calibrating results in the quantitative determination of hemoglobin A1c (HbA1c) in human blood by manual techniques and automatic analyzers. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment. For in vitro diagnostic use only. For professional use only.
Additional information URL: https://www.diagnostics.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101050302CALIBRATORS SINGLE COMPONENT (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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