Identity
- Trade Name
- GAMMAPRO HI-S EUDAMEDWPROBE FDA UDI
- Generic Name
- Intraoperative gamma radiation detection system probe, reusable FDA UDI
- Device Name
- GAMMAPRO EUDAMEDGAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG). FDA UDI
- Model / Reference
- STD, LAP, HI-S EUDAMEDIC-1160 EUDAMEDHI-S FDA UDI
- Description
- GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG). FDA UDI
Identifiers
- Catalog Number
- IC-1160 FDA UDI
- Primary DI / UDI-DI
- 08437018413096 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437018413GAMMAPROBE7U EUDAMED
- Direct Marketing DI
- 08437018413096 EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
- GMDN Term
- Intraoperative gamma radiation detection system probe, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Hydrogen Peroxide FDA UDI
Dimensions & Sizes
- Size
- Height — 40 Millimeter FDA UDILength — 255 Millimeter FDA UDIWeight — 182 Gram FDA UDIWidth — 40 Millimeter FDA UDI
Category: Hand-held-detector nuclear medicine system
Gammapro Hi-S by General Equipment For Medical Imaging, S.a. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand-held-detector nuclear medicine system.
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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 | 8437018413GAMMAPROBE7U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- General Equipment For Medical Imaging, S.a.
- EUDAMED SRN
- ES-MF-000013779
Sources (2)
- EUDAMED 9a837f5a-0d87-47ac-8dce-7dd4560860fe 61 fields · synced Jul 25, 2026
- FDA UDI 094c31d5-eb59-4021-b421-0771da7862f2 36 fields · synced May 22, 2026