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Sonata Radiofrequency Ablation Handpiece
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref RFA-002
Identity
- Trade Name
- Sonata Radiofrequency Ablation Handpiece EUDAMEDSonata® Radiofrequency Ablation Handpiece FDA UDI
- Generic Name
- Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode FDA UDI
- Device Name
- Sonata Radiofrequency Ablation Handpiece EUDAMEDUltrasound-guided intrauterine electrosurgical handpiece/ electrode FDA UDI
- Model / Reference
- RFA-002 EUDAMEDFDA UDI
- Description
- Ultrasound-guided intrauterine electrosurgical handpiece/ electrode FDA UDI
Identifiers
- Catalog Number
- RFA-002 FDA UDI
- Primary DI / UDI-DI
- 10817929020371 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902RFAHPD5 EUDAMED
- Direct Marketing DI
- 10817929020371 EUDAMED
- 510(k) Number
- K211535 FDA UDI
- FDA Product Code
- KNF FDA UDI
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sonata Radiofrequency Ablation Handpiece by Gynesonics, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081792902RFAHPD5 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Gynesonics, Inc.
- EUDAMED SRN
- US-MF-000017044
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1695164b-305a-4b44-80b5-bd26ae3e6c01 61 fields · synced Sep 17, 2026
- FDA UDI 595d6d08-a99c-4adf-a1e8-b83730fcd7ee 37 fields · synced May 30, 2026