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AUTODXTM Analyzer
EUDAMEDClass A (EU MDR)
Ref E1M100Model Ep.414
by DxGen Corp.
Identity
- Trade Name
- AUTODXTM Analyzer EUDAMED
- Model / Reference
- Ep.414 EUDAMEDE1M100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800031900063 EUDAMED
- Basic UDI-DI
- 88000319RAMS0JY EUDAMED
- Direct Marketing DI
- 08800031900063 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
AUTODXTM Analyzer by DxGen Corp. — 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 | 88000319RAMS0JY | Class A | Active |
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Manufacturer
- Manufacturer
- DxGen Corp.
- EUDAMED SRN
- KR-MF-000030876
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED b2033f63-f8d7-4695-b4f4-d197f6f154d2 61 fields · synced Jun 18, 2026