Identity
- Trade Name
- DYSIS View EUDAMEDFDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- DYSIS Ultra 3.0 Digital Colposcope EUDAMEDDYSIS 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 5 components; PC, BASE Assembly, ARM, Optical Head Unit and Touch Screen Monitor. FDA UDI
- Model / Reference
- DYSIS Ultra 3.0 EUDAMEDVIE001 EUDAMEDFDA 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 5 components; PC, BASE Assembly, ARM, Optical Head Unit and Touch Screen Monitor. FDA UDI
Identifiers
- Catalog Number
- VIE001 FDA UDI
- Primary DI / UDI-DI
- 05060477110263 EUDAMEDFDA UDI
- Basic UDI-DI
- 506047711COLED EUDAMED
- Direct Marketing DI
- 05060477110263 EUDAMED
- 510(k) Number
- K092433 FDA UDI
- FDA Product Code
- HEX FDA UDI
- EMDN Code
- Z12020703 COLPOSCOPES EUDAMED
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1630 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DYSIS View by DYSIS Medical LTD — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506047711COLED | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DYSIS Medical LTD
- EUDAMED SRN
- UK-MF-000038215
- Authorised Representative
- DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ EL-AR-000037572
Sources (2)
- EUDAMED 54dfcc26-987d-4e4b-b8bd-132b7798fabf 61 fields · synced Jun 18, 2026
- FDA UDI 401bdf40-6260-40eb-a153-d251387b50d2 35 fields · synced May 30, 2026