Identity
- Trade Name
- Genexus™ Dx Strip 2-HD EUDAMED
- Device Name
- Ion Torrent™ Genexus™ Dx Library Strips 1 and 2-HD, a part of Ion Genexus™ Dx Reagents and Consumables EUDAMED
- Model / Reference
- A50861 (A50430, A50430RR) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302017473 EUDAMED
- Basic UDI-DI
- 0190302A50430R8 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 2-HD 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 | 0190302A50430R8 | 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 (2)
- EUDAMED 7281f26f-d001-4492-9f9e-cdb7607d4f7e 61 fields · synced Jul 28, 2026
- EUDAMED 7281f26f-d001-4492-9f9e-cdb7607d4f7e-1 61 fields · synced Jun 9, 2026