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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

HBAFr-01.1 — IVDD — General IVDD by Streekziekenhuis…

MD Atlas
Streekziekenhuis Koningin Beatrix

EUDAMED last updated this device on May 15, 2026

HBAFr-01.1

B-87205897082118

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Streekziekenhuis Koningin Beatrix
UDI-DI code: 87205897082118
Reference / catalog number: HBAFr-01.1

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Manufacturer information

Organization name: Streekziekenhuis Koningin Beatrix
SRN: NL-MF-000000427
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 87205897082118
Basic UDI-DI: B-87205897082118
Reference / catalog number: HBAFr-01.1
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: Beoogd gebruik HbA1c, ingevroren volbloed is een niet-geautomatiseerd in vitro diagnostisch medisch hulpmiddel dat bedoeld is voor gebruik door beroepsbeoefenaren in de gezondheidszorg als referentiemateriaal bij HbA1c-metingen voor de kwantitatieve bepaling van HbA1c in bloed. Het materiaal is bedoeld ter ondersteuning van kalibratie- of kwaliteitscontroleprocedures bij HbA1c-testen die worden gebruikt voor het voorspellen van diabetes en het monitoren van de glycemische controle en de respons op de behandeling bij patiënten met diabetes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101050302CALIBRATORS SINGLE COMPONENT (CC)
W0101050205DIABETES CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.