Identity
- Trade Name
- Lara Reader EUDAMEDFDA UDI
- Generic Name
- Scintillation-counter radiation survey meter FDA UDI
- Device Name
- Lara System EUDAMED
- Model / Reference
- 401874-100 EUDAMED401874-230 EUDAMEDB FDA UDI
Identifiers
- Catalog Number
- 401874-230 FDA UDI
- Primary DI / UDI-DI
- 00850014578008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014578LaraSystemLD2WJ EUDAMED
- Direct Marketing DI
- 00850014578008 EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
- GMDN Term
- Scintillation-counter radiation survey meter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held-detector nuclear medicine system
Lara Reader by Lucerno Dynamics, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850014578LaraSystemLD2WJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lucerno Dynamics, LLC
- EUDAMED SRN
- US-MF-000001351
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 799567b5-8892-420f-ac82-2b7284a38f00 61 fields · synced Jun 19, 2026
- FDA UDI 6a7b27e8-e39c-47ca-9000-84a00344193f 35 fields · synced May 30, 2026