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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

HbA1c CONTROL L + H — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Mar 25, 2026

HbA1c CONTROL L + H

37017008HBAC0532

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700821212
Reference / catalog number: HBAC-4605

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Manufacturer information

Organization name: VitalScientific
SRN: FR-MF-000004722
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
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jun 6, 2024	Still on market

Device identification

Trade name: HbA1c CONTROL L + H
UDI-DI code: 03701700821212
Basic UDI-DI: 37017008HBAC0532
Reference / catalog number: HBAC-4605
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: "This in vitro diagnostic device is intended for the quality control of the performances of reagents, used for HbA1c quantitative determination. This in vitro diagnostic device is for professional use only."
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102152003SPECIFIC PROTEIN CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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