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Kegel8
EUDAMEDClass I (EU MDR)
Ref 13928-SIZE3Model Kegel8 Vaginal DilatorsRef 13928-SIZE5Ref 13963Model Kegel8 Pelvic Therapy WandRef 13965Model Kegel8 Anal DilatorsRef 13965-SIZE4Ref 13965-SIZE2Ref 13928-SIZE4Ref 13928-SETRef 13928-SIZE1Ref 13965-SIZE5Ref 13928-SIZE2
Identity
- Trade Name
- Kegel8 EUDAMED
- Device Name
- Set EUDAMEDKegel8 Pelvic Therapy Wand EUDAMED
- Model / Reference
- Kegel8 Vaginal Dilators EUDAMED13928-SIZE3 EUDAMED13928-SIZE5 EUDAMEDKegel8 Pelvic Therapy Wand EUDAMED13963 EUDAMEDKegel8 Anal Dilators EUDAMED13965 EUDAMED13965-SIZE4 EUDAMED13965-SIZE2 EUDAMED13928-SIZE4 EUDAMED13928-SET EUDAMED13928-SIZE1 EUDAMED13965-SIZE5 EUDAMED13928-SIZE2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055896944872 EUDAMED05055896944919 EUDAMED05055896944315 EUDAMED05055896944469 EUDAMED05055896945497 EUDAMED05055896945466 EUDAMED05055896944902 EUDAMED05055896945442 EUDAMED05055896944834 EUDAMED05055896945510 EUDAMED05055896944858 EUDAMED
- Basic UDI-DI
- 50558969139287W EUDAMED50558969139637Y EUDAMED505589691396584 EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMEDU0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMEDL040902 RECTAL AND ANAL SPREADERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDSpain 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 | 50558969139287W | 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 (11)
- EUDAMED e57dfbd5-b2f5-474e-a7f7-6df652d583c4 61 fields · synced Oct 6, 2026
- EUDAMED d60d11cc-05a5-46ad-a7e6-f23c15108e8b 61 fields · synced May 17, 2026
- EUDAMED c1ae90bf-28f1-46d8-b953-2847636a4a3e 61 fields · synced May 17, 2026
- EUDAMED b23938e7-cf41-49e9-ac35-d03d56ffc836 61 fields · synced May 17, 2026
- EUDAMED 291aa33e-73b3-4c76-88fc-ab9b0e4f9bfa 61 fields · synced May 18, 2026
- EUDAMED 7fd9c951-8c51-448b-8d11-014c9700ff2d 61 fields · synced May 18, 2026
- EUDAMED fb342a22-a4a7-45d6-a253-d4421654d9e0 61 fields · synced May 18, 2026
- EUDAMED 78956bde-b5c0-4423-ae73-4abaab8b2926 61 fields · synced May 18, 2026
- EUDAMED ecda45db-b8ed-43ff-9ddd-48c3c1c76735 61 fields · synced May 18, 2026
- EUDAMED 5a931c74-efa3-4223-b46e-152b2af8b075 61 fields · synced May 19, 2026
- EUDAMED 1f71f53a-cbe2-4d53-9dde-04ecb6768924 61 fields · synced May 19, 2026