Identity
- Trade Name
- DYSIS Ultra 3.0 EUDAMED
- Device Name
- DYSIS Ultra 3.0 Digital Colposcope EUDAMED
- Model / Reference
- DYSIS Ultra 3.0 EUDAMEDDYS404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060477110270 EUDAMED
- Basic UDI-DI
- 506047711COLED EUDAMED
- Direct Marketing DI
- 05060477110270 EUDAMED
- EMDN Code
- Z12020703 COLPOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
DYSIS Ultra 3.0 by DYSIS Medical LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506047711COLED | Class IIa | Active |
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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 (1)
- EUDAMED 4daba566-be73-4835-94c2-50635ee88ce6 61 fields · synced Jun 19, 2026