Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

xPOC Cartridge — IVDR Class A IVDR by GENSPEED Biotech

MD Atlas
GENSPEED Biotech

EUDAMED last updated this device on Apr 27, 2026

xPOC Cartridge

912013177xPOCCartS4

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: GENSPEED Biotech
UDI-DI code: 09120131770038
Reference / catalog number: GSPC2

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	May 29, 2025	Still on market

Device identification

Trade name: xPOC Cartridge
UDI-DI code: 09120131770038
Basic UDI-DI: 912013177xPOCCartS4
Reference / catalog number: GSPC2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The xPOC Cartridge is an in vitro diagnostic accessory for use at the point of care in combination with the GENSPEED xPOC test kits. It is intended to be used by healthcare professionals only and not for self-testing.
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

Related devices

IATK216B-09120131770069On the market GENSPEED R2 Analyzer912013177R2analyzerL7On the market Perio POC Pro Cartridge912013177DNACartE8On the market PerioPOC ProB-09120131770052On the market IATK215912013177VitaminD3CJOn the market

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