← Back to catalogue
DYSIS Disposable Speculum
EUDAMEDClass I (EU MDR)
Ref DSP001Model DYSIS Disposable SpeculumRef DSP003
Identity
- Trade Name
- DYSIS Disposable Speculum EUDAMED
- Device Name
- DYSIS Disposable Speculum (small) EUDAMED
- Model / Reference
- DYSIS Disposable Speculum EUDAMEDDSP001 EUDAMEDDSP003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060477110034 EUDAMED05060477110058 EUDAMED
- Basic UDI-DI
- 506047711DSPF6 EUDAMED
- Direct Marketing DI
- 05060477110034 EUDAMED05060477110058 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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 Disposable Speculum by DYSIS Medical LTD — Class I — 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 | 506047711DSPF6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 494f42cd-c1dd-4fd8-9130-64327ac99934 61 fields · synced Jun 20, 2026
- EUDAMED dafe67d7-d295-4fa2-8996-49b36197172a 61 fields · synced May 17, 2026