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Organization name
UDI-DI code
Reference / catalog number

HbA1c Enzymatic — IVDR Class B IVDR by VitalScientific

MD Atlas
VitalScientific

EUDAMED last updated this device on Mar 25, 2026

HbA1c Enzymatic

37017008HBAE0134

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: VitalScientific
UDI-DI code: 03701700804413
Reference / catalog number: HBAE-5M30

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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 Enzymatic
UDI-DI code: 03701700804413
Basic UDI-DI: 37017008HBAE0134
Reference / catalog number: HBAE-5M30
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 reagent is intended for the quantitative determination of HbA1c in human whole blood samples on Selectra Mach Series analyzers. This in vitro diagnostic reagent 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)

W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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