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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

Perio POC Pro Cartridge — IVDR Class A IVDR by GENSPEED Biotech

MD Atlas
GENSPEED Biotech

EUDAMED last updated this device on Apr 27, 2026

Perio POC Pro Cartridge

912013177DNACartE8

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: 09120131770045
Reference / catalog number: GSPC3

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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 9, 2025	Still on market

Device identification

Trade name: Perio POC Pro Cartridge
UDI-DI code: 09120131770045
Basic UDI-DI: 912013177DNACartE8
Reference / catalog number: GSPC3
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 PerioPOCPro Cartridge is an in vitro diagnostic accessory for use at the point of care in combination with the GENSPEED PerioPOCPro test kit. 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)

W0105011699BACTERIOLOGY - NA REAGENTS - 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
Technical documentationNotified body: 2962Expiry: Sep 4, 2029
IQMS/00002/0v001Issued
Quality management systemNotified body: 2962Expiry: Sep 4, 2029