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Sentinella Horus
EUDAMEDClass IIa (EU MDR)
Ref FP-0075Model SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUSRef FP-0070
Identity
- Trade Name
- SENTINELLA HORUS EUDAMEDSENTINELLA EUDAMED
- Device Name
- SENTINELLA EUDAMED
- Model / Reference
- SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS EUDAMEDFP-0075 EUDAMEDFP-0070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437018413287 EUDAMED08437018413270 EUDAMED
- Basic UDI-DI
- 8437018413GAMMACAMERAN4 EUDAMED
- Direct Marketing DI
- 08437018413287 EUDAMED08437018413270 EUDAMED
- EMDN Code
- Z11020101 MOBILE GAMMA CAMERAS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Sentinella Horus by General Equipment For Medical Imaging, S.a. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8437018413GAMMACAMERAN4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- General Equipment For Medical Imaging, S.a.
- EUDAMED SRN
- ES-MF-000013779
Sources (2)
- EUDAMED 3efc81cf-7fb0-4f47-9615-f51e588480b5 61 fields · synced Jul 30, 2026
- EUDAMED ff11b91b-bcb6-4ed4-a4a9-ef6ad3d921d8 61 fields · synced May 18, 2026