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Sedecal
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref SHF-515-CModel X-RAY GENERATOR SHF, X-RAY GENERATOR SHFR
Identity
- Trade Name
- SEDECAL FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- Radiographic System EUDAMEDHigh frequency diagnostic x-ray generator FDA UDI
- Model / Reference
- SHF-515-C EUDAMEDFDA UDIX-RAY GENERATOR SHF, X-RAY GENERATOR SHFR EUDAMED
- Description
- High frequency diagnostic x-ray generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436046000636 EUDAMEDFDA UDI
- Basic UDI-DI
- 843604600GENERATORBD EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
- GMDN Term
- Diagnostic x-ray system generator, stationary FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 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
Yes
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
Yes
FDA UDI
Category: Diagnostic x-ray system generator, stationary
Sedecal by Sedecal., Sa. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Diagnostic x-ray system generator, stationary.
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- EDITOR HFe 601 — Spellman High Voltage Electronics GmbH · Class IIb
- iRay — Iray Imaging Technology (Haining) Limited · Class I
- QG-40-3 — CARESTREAM HEALTH, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sedecal., Sa.
Sources (2)
- FDA UDI 91eda6da-4991-480a-8465-c91775e20f6a 34 fields · synced Sep 17, 2026
- EUDAMED 81f1f0cf-3f19-43e7-9779-20621801189d 61 fields · synced Sep 17, 2026