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Esteya

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
Esteya FDA UDI
Generic Name
Skin-tumour low-voltage therapeutic x-ray system FDA UDI
Device Name
Surface Applicator, 10mm FDA UDI
Model / Reference
187124P01-03 FDA UDI
Description
Surface Applicator, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI
08717213050983 FDA UDI
510(k) Number
K132092 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 10.0 Millimeter FDA UDI

Category: Skin-tumour low-voltage therapeutic x-ray system

Esteya by Nucletron B.V. — 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.

Cleared under the same submission

K132092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nucletron B.V.

Sources (1)

  • FDA UDI 4e7b960f-9856-4664-9bc6-d50f9321627c 36 fields · synced May 30, 2026