Vagispec Kolplast

FDA UDI

Class II (US FDA UDI)

by Kolplast CI SA

Identity

Trade Name: VAGISPEC KOLPLAST FDA UDI
Generic Name: Vaginal speculum, single-use FDA UDI
Model / Reference: ESPEC VAG VAGISPEC G LUB E FDA UDI

Identifiers

Catalog Number: 900700923 FDA UDI
Primary DI / UDI-DI: 07898027902130 FDA UDI
510(k) Number: K973853 FDA UDI
FDA Product Code: HIB FDA UDI
GMDN Term: Vaginal speculum, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vaginal speculum, single-use

Vagispec Kolplast by Kolplast CI SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal speculum, single-use.

Henry Schein — HENRY SCHEIN, INC. · Class II
Sklar® — Sklar Corporation · Class I
Sklar® — Sklar Corporation · Class I
AMSure® Disposable Vaginal Speculum — AMSINO INTERNATIONAL, INC. · Class II
Centurion — Centurion Medical Products · Class II
Vaginal Speculum — Dynarex Corp. · Class II
Sklar — Sklar Corporation · Class I
Welch Allyn, Inc. — Welch Allyn, Inc. · Class II

Cleared under the same submission

K973853 also covers:

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 9bb5a49e-e84c-4d0d-8949-1b05f278f288 34 fields · synced May 30, 2026