Identity
- Trade Name
- Mic IVD Automation EUDAMED
- Device Name
- Mic IVD EUDAMED
- Model / Reference
- Mic IVD EUDAMEDMIC-IVD AUTOMATION EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09357795000038 EUDAMED
- Basic UDI-DI
- 93577950MicIVDG7 EUDAMED
- Direct Marketing DI
- 09357795000038 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Mic IVD Automation by Bio-Molecular Systems 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 | 93577950MicIVDG7 | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Molecular Systems Pty Ltd
- EUDAMED SRN
- AU-MF-000025328
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED b218d8c5-ba73-4af9-8c69-65436a4b963e 61 fields · synced Jun 19, 2026