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Epithod®616 Analyzer
EUDAMEDClass A (EU MDR)
Ref E0M100Model Ep.616
by DxGen Corp.
Identity
- Trade Name
- Epithod®616 Analyzer EUDAMED
- Model / Reference
- Ep.616 EUDAMEDE0M100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800031900025 EUDAMED
- Basic UDI-DI
- 88000319RHRA2KQ EUDAMED
- Direct Marketing DI
- 08800031900025 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Epithod®616 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 | 88000319RHRA2KQ | 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 52908967-3a90-442e-8186-3e638a151a71 61 fields · synced Jul 11, 2026