Identity
- Trade Name
- Kegel8 EUDAMED
- Device Name
- Set EUDAMED
- Model / Reference
- Kegel8 Anal Dilators EUDAMED13965-SIZE1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055896945459 EUDAMED
- Basic UDI-DI
- 505589691396584 EUDAMED
- EMDN Code
- L040902 RECTAL AND ANAL SPREADERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Kegel8 by Savantini 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 | 505589691396584 | Class I | Active |
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Manufacturer
- Manufacturer
- Savantini Ltd
- EUDAMED SRN
- GB-MF-000011959
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED a0d3642f-d981-4fde-bb32-b92376abc001 61 fields · synced Jun 19, 2026