Identity
- Trade Name
- Low DNA Reagent Reservoir (4 pack) EUDAMED
- Device Name
- Nucleic acid amplification mastermix reagent IVD EUDAMED
- Model / Reference
- 40431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044003660 EUDAMED
- Basic UDI-DI
- 93430440W010590010259 EUDAMED
- Direct Marketing DI
- 09343044003660 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
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
Low DNA Reagent Reservoir (4 pack) by AusDiagnostics Pty Ltd — 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 | 93430440W010590010259 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AusDiagnostics Pty Ltd
- EUDAMED SRN
- AU-MF-000020558
- Authorised Representative
- R-Biopharm AG DE-AR-000050025
Sources (1)
- EUDAMED 847a99bb-4746-47a0-81d2-aab7759a1773 61 fields · synced Jul 21, 2026