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Europrobe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SOE3216-D-ACModel EUROPROBE 3.2
by Eurorad 2-6
Identity
- Trade Name
- EUROPROBE EUDAMEDFDA UDI
- Generic Name
- Hand-held-detector nuclear medicine system FDA UDI
- Device Name
- EUROPROBE EUDAMEDEUROPROBE 3.2 PROBE FDA UDI
- Model / Reference
- EUROPROBE 3.2 EUDAMEDSOE3216-D-AC EUDAMED3.2 FDA UDI
- Description
- EUROPROBE 3.2 PROBE FDA UDI
Identifiers
- Catalog Number
- SOE3216-D-AC FDA UDI
- Primary DI / UDI-DI
- 03700542200353 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005422000000EUROPROBEKJ EUDAMED
- Direct Marketing DI
- 03700542200353 EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
- GMDN Term
- Hand-held-detector nuclear medicine system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Europrobe by Eurorad 2-6 — Class IIa — 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 | 37005422000000EUROPROBEKJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Eurorad 2-6
- EUDAMED SRN
- FR-MF-000000156
Sources (2)
- EUDAMED 990f2891-c738-4ea3-951d-34d81d763d05 61 fields · synced Jul 16, 2026
- FDA UDI ac9981c1-3163-4a08-9d0e-303d4b3e476a 36 fields · synced May 30, 2026