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Sonata Dispersive Electrode
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DE-002Ref DE-001
Identity
- Trade Name
- Sonata Dispersive Electrode EUDAMEDSonata® Dispersive Electrode FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- Sonata Dispersive Electrode EUDAMEDElectrosurgical return electrode, single-use FDA UDI
- Model / Reference
- DE-002 EUDAMEDDE-001 EUDAMEDFDA UDI
- Description
- Electrosurgical return electrode, single-use FDA UDI
Identifiers
- Catalog Number
- DE-001 FDA UDI
- Primary DI / UDI-DI
- 30817929020474 EUDAMED10817929020364 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902RFDEEB EUDAMED
- Direct Marketing DI
- 10817929020364 EUDAMED
- FDA Product Code
- KNF FDA UDI
- EMDN Code
- Z12080299 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use 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
No
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 Dispersive Electrode 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 | 081792902RFDEEB | 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 (3)
- EUDAMED 0922fe2d-2140-4b98-81e2-8941a89ea464 61 fields · synced Jul 10, 2026
- EUDAMED a5f96779-a523-45a2-8315-263834df36ad 61 fields · synced May 18, 2026
- FDA UDI 6e2e1fe0-3d7a-47f4-be55-5c43da836bcb 36 fields · synced May 29, 2026