Identity
- Device Name
- AutoXT Total gDNA Kit EUDAMED
- Model / Reference
- 17188-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809054870391 EUDAMED
- Basic UDI-DI
- 88090548717188-96VF EUDAMED
- Direct Marketing DI
- 08809054870391 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia 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
Category: Nucleic acid sample preparation instrument IVD
AutoXT Total gDNA Kit by iNtRON Biotechnology — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 88090548717188-96VF | Class A | Active |
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Manufacturer
- Manufacturer
- iNtRON Biotechnology
- EUDAMED SRN
- KR-MF-000036507
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED dc059567-6b2b-4fa6-a82b-cea93017c249 61 fields · synced Jun 19, 2026