Identity
- Device Name
- Transducer EUDAMED
- Model / Reference
- UT-I EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138610608 EUDAMED
- Basic UDI-DI
- 69571386UT19Z3 EUDAMED
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Category: Ultrasonic surgical system generator
Transducer by Tianjin Huahong Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69571386UT19Z3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 70486958-986a-4c02-a50e-20e8d0274f99 61 fields · synced Jun 18, 2026