Identity
- Trade Name
- Miconvey EUDAMED
- Device Name
- Ultrasonic Surgical Handpiece EUDAMED
- Model / Reference
- QUBP35 EUDAMEDQUHP35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974710250939 EUDAMED
- Basic UDI-DI
- 697471025QUHP35RQ EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Miconvey by Miconvey Technologies Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697471025QUHP35RQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Miconvey Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031532
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9c09318b-0a69-43b2-9196-d66090fd2c5b 61 fields · synced Jun 9, 2026