Kolplast

FDA UDI

Class II (US FDA UDI)

by Kolplast CI SA

Identity

Trade Name: KOLPLAST FDA UDI
Generic Name: General-purpose light source FDA UDI
Device Name: Wireless LED light source for vaginal speculum. Provides illumination during pelvic examination and other gynecological procedures. FDA UDI
Model / Reference: Wireless FDA UDI
Description: Wireless LED light source for vaginal speculum. Provides illumination during pelvic examination and other gynecological procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 07898027903601 FDA UDI
FDA Product Code: FTD FDA UDI
GMDN Term: General-purpose light source FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose light source

Kolplast by Kolplast CI SA — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Kolplast CI SA

Sources (1)

FDA UDI 6cca1a6b-3a71-43e7-acd2-df71ab6d575e 34 fields · synced Jun 1, 2026