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Sonata Intrauterine Ultrasound Probe, non-sterile
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IUSP-002
Identity
- Trade Name
- Sonata Intrauterine Ultrasound Probe, non-sterile EUDAMEDSonata® Intrauterine Ultrasound Probe FDA UDI
- Generic Name
- Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable FDA UDI
- Device Name
- Sonata Intrauterine Ultrasound Probe EUDAMEDUltrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer FDA UDI
- Model / Reference
- IUSP-002 EUDAMEDFDA UDI
- Description
- Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer FDA UDI
Identifiers
- Catalog Number
- IUSP-002 FDA UDI
- Primary DI / UDI-DI
- 30817929020092 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902IUSPGS EUDAMED
- Direct Marketing DI
- 30817929020092 EUDAMED
- FDA Product Code
- ITX FDA UDIKNF FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI884.4160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sonata Intrauterine Ultrasound Probe, non-sterile by Gynesonics, Inc. — Class IIa — 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 | 081792902IUSPGS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 412e0bf8-5252-4341-b27e-fc849e878a5f 61 fields · synced Jun 18, 2026
- FDA UDI 18a70b4a-126c-4a51-b3a6-f7251ba9a7fa 36 fields · synced May 30, 2026