Identity
- Device Name
- LOAA-M Console EUDAMED
- Model / Reference
- LAM303-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809740940063 EUDAMED
- Basic UDI-DI
- 880974094LAM303HV EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
LOAA-M Console by OPTOLANE Technologies Inc. — 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 | 880974094LAM303HV | Class A | Active |
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Manufacturer
- Manufacturer
- OPTOLANE Technologies Inc.
- EUDAMED SRN
- KR-MF-000026042
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 5a926993-6f5e-4060-82f4-b5f56feb936c 61 fields · synced Jun 17, 2026