Identity
- Trade Name
- Genexus™ Dx Strip 4 EUDAMED
- Device Name
- Ion Torrent™ Genexus™ Dx Templating Strips 3-GX5™ and 4, a part of Ion Genexus™ Dx Reagents and Consumables EUDAMED
- Model / Reference
- A50863 (A50431) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302017497 EUDAMED
- Basic UDI-DI
- 0190302A50431RA EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Genexus™ Dx Strip 4 by Life Technologies Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302A50431RA | Class A | Active |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
- EUDAMED SRN
- US-MF-000023929
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED 09afd47e-5183-47d6-b661-d3ac1a09bc06 61 fields · synced Jul 12, 2026