Lara Sensor, Type 1
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Lara Sensor, Type 1 EUDAMEDFDA UDI
- Generic Name
- Scintillation-counter radiation survey meter FDA UDI
- Device Name
- Lara System EUDAMED
- Model / Reference
- 401874-100 EUDAMED401874-220-1 EUDAMEDD FDA UDI
Identifiers
- Catalog Number
- 401874-220-1 FDA UDI
- Primary DI / UDI-DI
- 00850014578015 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014578LaraSystemLD2WJ EUDAMED
- Direct Marketing DI
- 00850014578015 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Hand-held-detector nuclear medicine system
Lara Sensor, Type 1 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
CE/MDR
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 471a34aa-22f2-4559-972d-c51f5f35f65e 61 fields · synced Jun 17, 2026
- FDA UDI f60285f4-5eee-4244-af97-ad9bd2e5c51e 35 fields · synced May 30, 2026