Identity
- Trade Name
- Ultrasonic Transducer EUDAMEDSonicure FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Ultrasonic Transducer EUDAMED
- Model / Reference
- SC100T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972304750329 EUDAMEDFDA UDI
- Basic UDI-DI
- 69723047500106Q EUDAMED
- 510(k) Number
- K212614 FDA UDI
- FDA Product Code
- LFL FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Soft-tissue ultrasonic surgical system
Sonicure by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K212614 also covers:
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 3dc6d9fe-6954-4d55-97fe-ff8b22293f29 33 fields · synced Jun 11, 2026
- EUDAMED 58733c5e-aa49-4363-9b91-b94d9eed9a16 61 fields · synced Jun 11, 2026