DYSIS Ultra 2.0

FDA UDI

Class II (US FDA UDI)

by Dysis Medical Limited

Identity

Trade Name: DYSIS Ultra 2.0 FDA UDI
Generic Name: Colposcope FDA UDI
Device Name: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 6 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit and Clinician Touch Screen Monitor. FDA UDI
Model / Reference: DYS403 FDA UDI
Description: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 6 components; PC, BASE Assembly, Optical ARM Assembly (ARMO), Display ARM Assembly (ARMD), Optical Head Unit and Clinician Touch Screen Monitor. FDA UDI

Identifiers

Primary DI / UDI-DI: 05060477110188 FDA UDI
510(k) Number: K092433 FDA UDI
FDA Product Code: HEX FDA UDI
GMDN Term: Colposcope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1630 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Colposcope

DYSIS Ultra 2.0 by Dysis Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Colposcope.

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Henry Schein — HENRY SCHEIN, INC. · Class II
MICROSTAR Colposcope — Ecleris · Class II
Gynex — GYNEX CORPORATION · Class II
MICROSCOPE Colposcope — Ecleris · Class II
WALLACH — CooperSurgical, Inc. · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II

Cleared under the same submission

K092433 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: Dysis Medical Limited

Sources (1)

FDA UDI 50211cb7-e0eb-42dd-b465-398ffcd8ca9c 35 fields · synced Jun 6, 2026