Identity
- Trade Name
- HESTIA EUDAMEDGenoray FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- HESITA EUDAMED
- Model / Reference
- 507 EUDAMEDHESTIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244065088 EUDAMEDFDA UDI
- Basic UDI-DI
- 880924406HESTIALR EUDAMED
- 510(k) Number
- K243420 FDA UDI
- FDA Product Code
- MUE FDA UDI
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1715 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hestia by Genoray Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243420 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880924406HESTIALR | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 98e0887f-3927-4df4-9bfb-930fcc0f4437 61 fields · synced Jul 20, 2026
- FDA UDI e014c6cf-79e7-4c5d-a636-7e0233da885f 33 fields · synced May 30, 2026
- FDA 510(k) K243420 1 fields · synced May 18, 2026