Identity
- Trade Name
- SRT-100 Vision™ EUDAMEDSensus FDA UDI
- Generic Name
- Skin-tumour low-voltage therapeutic x-ray system FDA UDI
- Device Name
- SRT-100 Vision™ EUDAMED
- Model / Reference
- SRT-100 Vision™ EUDAMEDSRT-100 Vision FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850002237020 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10850002237020 EUDAMED
- 510(k) Number
- K150037 FDA UDI
- FDA Product Code
- JAD FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Skin-tumour low-voltage therapeutic x-ray system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5900 FDA UDI
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin-tumour low-voltage therapeutic x-ray system
Sensus by Sensus Healthcare — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sensus Healthcare
Sources (2)
- FDA UDI 7a01086e-e8d4-4794-b39e-386b35f91cfc 33 fields · synced Jul 20, 2026
- EUDAMED 286dbc24-89da-4716-b3a7-1415f8cb1ed8 61 fields · synced Jul 20, 2026