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

IATK216 — IVDD — General IVDD by GENSPEED Biotech

MD Atlas
GENSPEED Biotech

EUDAMED last updated this device on Apr 27, 2026

IATK216

B-09120131770069

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GENSPEED Biotech
UDI-DI code: 09120131770069
Reference / catalog number: IATK216

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

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	May 25, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120131770069
Basic UDI-DI: B-09120131770069
Reference / catalog number: IATK216
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: FSME IgG xPOC is a rapid test for the detection of TBE-specific immunoglobulin G in human blood samples. FSME IgG xPOC is to be used for near-patient testing by healthcare professionals only in combination with the automated GENSPEED R2 Analyzer. FSME IgG xPOC is not intended for the diagnosis of an TBE infection.
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

GENSPEED R2 Analyzer912013177R2analyzerL7On the market Perio POC Pro Cartridge912013177DNACartE8On the market PerioPOC ProB-09120131770052On the market IATK215912013177VitaminD3CJOn the market xPOC Cartridge912013177xPOCCartS4On the market

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