Soled15

FDA UDI

Class I (US FDA UDI)

by Acem Spa

Identity

Trade Name: SOLED15 FDA UDI
Generic Name: Mobile examination/treatment room light FDA UDI
Device Name: SOLED15 TROLLEY FDA UDI
Model / Reference: SOLED15 /T FDA UDI
Description: SOLED15 TROLLEY FDA UDI

Identifiers

Catalog Number: 110303 FDA UDI
Primary DI / UDI-DI: 08050705890279 FDA UDI
FDA Product Code: KZF FDA UDI
GMDN Term: Mobile examination/treatment room light FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile examination/treatment room light

Soled15 by Acem Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Acem Spa

Sources (1)

FDA UDI 68e98997-ca4d-4fff-a5ee-24f775d12b1b 34 fields · synced Jun 1, 2026