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Sensus

FDA UDI

Class II (US FDA UDI)

by Sensus Healthcare

Identity

Trade Name
Sensus FDA UDI
Generic Name
Skin-tumour low-voltage therapeutic x-ray system FDA UDI
Model / Reference
SRT-100+ FDA UDI

Identifiers

Primary DI / UDI-DI
10850002237037 FDA UDI
510(k) Number
K173425 FDA UDI
FDA Product Code
JAD FDA UDI
GMDN Term
Skin-tumour low-voltage therapeutic x-ray system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin-tumour low-voltage therapeutic x-ray system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sensus Healthcare

Sources (1)

  • FDA UDI 69d735c9-aaf9-478f-8456-8418eddb2070 33 fields · synced May 30, 2026