Identity
- Trade Name
- Lara QC Fixture EUDAMEDFDA UDI
- Generic Name
- Scintillation-counter radiation survey meter FDA UDI
- Device Name
- Lara System EUDAMED
- Model / Reference
- 401874-100 EUDAMED401874-200 EUDAMED2 FDA UDI
Identifiers
- Catalog Number
- 401874-200 FDA UDI
- Primary DI / UDI-DI
- 00850014578091 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014578LaraSystemLD2WJ EUDAMED
- Direct Marketing DI
- 00850014578091 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
Lara QC Fixture by Lucerno Dynamics, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 b992939c-0418-4cb6-8ec5-c97b35f1e963 61 fields · synced Jul 24, 2026
- FDA UDI c523e52c-9108-4ec2-9f26-38600ad5f451 34 fields · synced May 30, 2026