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Sonata® Transcervical Fibroid Ablation System
EUDAMEDClass IIb (EU MDR)
Ref SONATA2-220
Identity
- Trade Name
- Sonata® Transcervical Fibroid Ablation System EUDAMED
- Device Name
- Sonata® Transcervical Fibroid Ablation System EUDAMED
- Model / Reference
- SONATA2-220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10817929020333 EUDAMED
- Basic UDI-DI
- 081792902SONATAKA EUDAMED
- Direct Marketing DI
- 10817929020333 EUDAMED
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Sonata® Transcervical Fibroid Ablation System by Gynesonics, Inc. — Class IIb — 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 | 081792902SONATAKA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Gynesonics, Inc.
- EUDAMED SRN
- US-MF-000017044
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 38a2eac6-de37-4b15-b0bb-31fc74e2cd38 61 fields · synced Jul 17, 2026