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Organization name
UDI-DI code
Reference / catalog number

IATK215 — IVDR Class B IVDR by GENSPEED Biotech

MD Atlas
GENSPEED Biotech

EUDAMED last updated this device on Mar 23, 2026

IATK215

912013177VitaminD3CJ

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GENSPEED Biotech
UDI-DI code: 09120131770021
Reference / catalog number: IATK215

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Manufacturer information

Organization name: GENSPEED Biotech
SRN: AT-MF-000013008
Manufacturer status: Active

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 Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Sep 9, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120131770021
Basic UDI-DI: 912013177VitaminD3CJ
Reference / catalog number: IATK215
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: Vitamin D xPOC by GENSPEED Biotech is an in vitro diagnostic rapid test for the quantitative detection of 25(OH) Vitamin D3 in human capillary blood and serum samples. The result is given in ng/mL.
Additional information URL: https://www.genspeed-biotech.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

ITDA/00002/0v003Issued
refdata.certificate-ivdr-type.technical-documentationNotified body: 2962Expiry: Sep 4, 2029
IQMS/00002/0v001Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 2962Expiry: Sep 4, 2029