Europrobe
EUDAMEDFDA UDIClass IIa (EU MDR)
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 EUDAMEDSOE3211-AL-45 EUDAMED3.2 FDA UDI
- Description
- EUROPROBE 3.2 PROBE FDA UDI
Identifiers
- Catalog Number
- SOE3211-AL-45 FDA UDI
- Primary DI / UDI-DI
- 03700542200513 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005422000000EUROPROBEKJ EUDAMED
- Direct Marketing DI
- 03700542200513 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
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
No
Category: Hand-held-detector nuclear medicine system
Europrobe by Eurorad 2-6 — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held-detector nuclear medicine system.
- Gamma Finder® II — W.O.M. World of Medicine GmbH · Class I
- Lara Sensor, Type 7 — Lucerno Dynamics, LLC · Class I
- neoprobe — Devicor Medical Products, Inc. · Class I
- GAMMAPRO LAP — GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. · Class IIa
- Lara Sensor, Type 6 — Lucerno Dynamics, LLC · Class I
- neoprobe — Devicor Medical Products, Inc. · Class I
- Navigator Wireless Probe, 14mm Angled — Dilon Technologies, Inc. · Class I
- neoprobe — Devicor Medical Products, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurorad 2-6
- EUDAMED SRN
- FR-MF-000000156
Sources (2)
- EUDAMED 4adb06c9-23fe-439f-ade6-510c9b37cc77 61 fields · synced Jun 18, 2026
- FDA UDI 1b15f235-4567-4628-98c1-ea23efcfc3b2 36 fields · synced May 29, 2026