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Disposable Ultrasonic Surgical Scalpel
EUDAMEDClass IIb (EU MDR)
Ref QUHS36SRef QUHS14S
Identity
- Device Name
- Disposable Ultrasonic Surgical Scalpel EUDAMED
- Model / Reference
- QUHS36S EUDAMEDQUHS14S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974710250984 EUDAMED06974710250946 EUDAMED
- Basic UDI-DI
- B-06974710250984 EUDAMEDB-06974710250946 EUDAMED
- EMDN Code
- K0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Ultrasonic Surgical Scalpel by Miconvey Technologies Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974710250984 | 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 (2)
- EUDAMED e1fba0f8-cc60-4b26-bc2d-5f94abcf45b9 61 fields · synced Jul 8, 2026
- EUDAMED 1498fe38-8a3a-4e0a-ba35-38eb410fc032 61 fields · synced May 17, 2026